Trial Outcomes & Findings for COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis (NCT NCT04650087)
NCT ID: NCT04650087
Last Updated: 2025-02-25
Results Overview
Composite endpoint (CE) of venous and arterial thrombotic complications-including new, symptomatic proximal, or distal DVT of the upper or lower extremities, PE, and new thrombosis of other veins (including cerebral sinus and splanchnic veins), ischemic stroke, myocardial infarction, other arterial thromboembolism (e.g., mesenteric or acute limb ischemia), and all-cause mortality by day 30.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1291 participants
Primary outcome timeframe
30 days after hospital discharge
Results posted on
2025-02-25
Participant Flow
Participant milestones
| Measure |
Placebo
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
607
|
610
|
|
Overall Study
COMPLETED
|
581
|
578
|
|
Overall Study
NOT COMPLETED
|
26
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis
Baseline characteristics by cohort
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Total
n=1217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
n=5 Participants
|
54.1 years
n=7 Participants
|
54.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
303 Participants
n=5 Participants
|
311 Participants
n=7 Participants
|
614 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
304 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
603 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
103 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
484 Participants
n=5 Participants
|
487 Participants
n=7 Participants
|
971 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
363 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
713 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
154 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aboriginal or First Nations
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern or North African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
607 participants
n=5 Participants
|
610 participants
n=7 Participants
|
1217 participants
n=5 Participants
|
|
Medical history of Deep Vein Thrombosis (DVT)
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Medical History of Pulmonary Embolism (PE)
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after hospital dischargePopulation: intention-to-treat (ITT) population, including all participants randomized
Composite endpoint (CE) of venous and arterial thrombotic complications-including new, symptomatic proximal, or distal DVT of the upper or lower extremities, PE, and new thrombosis of other veins (including cerebral sinus and splanchnic veins), ischemic stroke, myocardial infarction, other arterial thromboembolism (e.g., mesenteric or acute limb ischemia), and all-cause mortality by day 30.
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.
|
2.31 percentage of participants
Interval 1.27 to 3.84
|
2.13 percentage of participants
Interval 1.14 to 3.62
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargePopulation: intention-to-treat (ITT) population, including all participants randomized
Composite endpoint of mortality and EQ5D index at Day 30. All mortality events will be considered worse than any possible EQ5D response \[QOL\&M30\]. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score.
|
0.93 score on a scale
Interval 0.78 to 1.0
|
0.93 score on a scale
Interval 0.75 to 1.0
|
SECONDARY outcome
Timeframe: 90 days after hospital dischargePopulation: intention-to-treat (ITT) population, including all participants randomized
Composite endpoint of mortality and EQ5D index at Day 90. All mortality events will be considered worse than any possible EQ5D response. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
The Composite Outcome of All-cause Mortality and the EQ5D Index Score.
|
0.94 score on a scale
Interval 0.76 to 1.0
|
0.94 score on a scale
Interval 0.74 to 1.0
|
SECONDARY outcome
Timeframe: 45 days after hospital dischargePopulation: intention-to-treat (ITT) population, including all participants randomized
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.
|
2.80 percentage of participants
Interval 1.64 to 4.44
|
2.46 percentage of participants
Interval 1.38 to 4.02
|
SECONDARY outcome
Timeframe: 90 days after hospital dischargePopulation: intention-to-treat (ITT) population, including all participants randomized
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.
|
2.80 percentage of participants
Interval 1.64 to 4.44
|
3.11 percentage of participants
Interval 1.89 to 4.82
|
SECONDARY outcome
Timeframe: 30 days after randomization (which occurred at time of hospital discharge)Population: intention-to-treat (ITT) population, including all participants randomized
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records.
|
0.82 percentage of participants
Interval 0.27 to 1.91
|
0.82 percentage of participants
Interval 0.27 to 1.9
|
SECONDARY outcome
Timeframe: 30 days after randomization (which occurred at time of hospital discharge)Population: intention-to-treat (ITT) population, including all participants randomized
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records.
|
0.49 percentage of participants
Interval 0.1 to 1.44
|
0.16 percentage of participants
Interval 0.0 to 0.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days following discharge from hospitalPopulation: intention-to-treat (ITT) population, including all participants randomized
Outcome measures
| Measure |
Placebo
n=607 Participants
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Apixaban
n=610 Participants
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
Percentage of Participants With All-cause Mortality
|
1.48 percentage of participants
Interval 0.68 to 2.8
|
1.31 percentage of participants
Interval 0.57 to 2.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days following discharge from hospitalOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 and 90 days following discharge from hospitalOutcome measures
Outcome data not reported
Adverse Events
Apixaban
Serious events: 71 serious events
Other events: 80 other events
Deaths: 12 deaths
Placebo
Serious events: 66 serious events
Other events: 90 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Apixaban
n=610 participants at risk
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Placebo
n=607 participants at risk
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
Infections and infestations
ACUTE APPENDICITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE ASTHMA EXACERBATION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
ACUTE DIFFUSE MYALGIAS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Immune system disorders
ACUTE REJECTION ON TRANSPLANTED KIDNEY
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Surgical and medical procedures
ALCOHOL DETOXIFICATION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA EXACERBATION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
General disorders
ATYPICAL CHEST PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
BILATERAL LOWER EXTREMITY CELLULITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
BILATERAL PULMONARY EMBOLI
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIOLITIS OBLITERANS ORGANIZING PNEUMONIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
C. DIFFICILE COLITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Cardiac disorders
CARDIAC ARREST
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
General disorders
CHEST PAIN
|
0.66%
4/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
CHRONIC SYSTOLIC HEART FAILURE
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
COMMUNITY ACQUIRED PNEUMONIA
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Nervous system disorders
COMPLEX MIGRAINES
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
COPD EXACERBATION
|
0.33%
2/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
COVID-19 REINFECTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
CRUSH INJURY
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
CYSTITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.33%
2/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
DIABETIC KETO ACIDOSIS
|
0.49%
3/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
GASTROINTESTINAL BLEED
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
GASTROINTESTINAL HEMORRHAGE
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
General disorders
GENERAL WEAKNESS
|
0.33%
2/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
GI BLEED
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Nervous system disorders
HEADACHES
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
HEMATEMESIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
HOSPITAL ACQUIRED PNEUMONIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Vascular disorders
LEFT LOWER EXTREMITY DVT
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
LLE CELLULITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Vascular disorders
LLE SUPERFICIAL THROMBOSIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
MITRAL VALVE REGURGITATION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
NEW ONSET DIABETES
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Cardiac disorders
NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
NON-ST ELEVATED MYOCARDIAL INFARCTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
OSTEOMYELITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
PNEUMONIA
|
0.82%
5/610 • Up to the 90 day visit
|
0.82%
5/607 • Up to the 90 day visit
|
|
Infections and infestations
POST COVID INFLAMMATORY LUNG DISEASE
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
POST COVID-19 SYNDROME
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
POST-COVID INFLAMMATORY SYNDROME
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
POST-SURGICAL INTRA-ABDOMINAL INFECTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLI
|
0.49%
3/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.16%
1/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
SIALADENITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
SIGMOID DIVERTICULITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
TENSION PNEUMOTHORAX
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACK
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
TRAUMATIC FOLEY INSERTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
ULCERATIVE PROCTITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
UNCONTROLLED DIABETES MELLITUS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
WORSENING ABSCESSES
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
WORSENING COLLAGENOUS COLITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
WORSENING COVID-19 INFECTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
WORSENING COVID-19 PNEUMONIA
|
1.6%
10/610 • Up to the 90 day visit
|
2.3%
14/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
WORSENING INTERSTITIAL LUNG DISEASE
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
WORSENING PATHOLOGICAL FRACTURE OF PELVIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
WORSENING PNEUMONIA
|
0.66%
4/610 • Up to the 90 day visit
|
0.49%
3/607 • Up to the 90 day visit
|
Other adverse events
| Measure |
Apixaban
n=610 participants at risk
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Apixaban 2.5 MG: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
Placebo
n=607 participants at risk
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Placebo: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Vascular disorders
ABNORMAL BLEEDING
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
ACUTE BACTERIAL SINUSITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Reproductive system and breast disorders
ACUTE PROSTATITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
ANGIONEUROTIC EDEMA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Reproductive system and breast disorders
BALANITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
BILATERAL KNEE PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
General disorders
BILATERAL LEG EDEMA
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
BILATERAL LEG PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
General disorders
BILATERAL LEG SWELLING
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
BILATERAL LOWER EXTREMITY PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
CELLULITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
CELLULITIS OF THE RIGHT LOWER EXTREMITY
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Nervous system disorders
CERVICAL RADICULOPATHY
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
General disorders
CHEST PAIN
|
0.49%
3/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
General disorders
CHEST TIGHTNESS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
COMMUNITY ACQUIRED PNEUMONIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Nervous system disorders
COMPLEX MIGRAINES
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Nervous system disorders
COMPLEX REGIONAL PAIN SYNDROME
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
COPD EXACERBATION
|
0.49%
3/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
COVID-19 CHRONIC DYSPNEA
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
COVID-19 PNEUMONITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
DECONDITIONED MUSCLES
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
DENTAL PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
DIARRHEA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
General disorders
EDEMA
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Investigations
ELEVATED D-DIMER
|
0.00%
0/610 • Up to the 90 day visit
|
0.66%
4/607 • Up to the 90 day visit
|
|
Investigations
ELEVATED LIVER ENZYMES
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
ESOPHAGEAL SPASM
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
FACIAL DERMATITIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
FALL
|
0.66%
4/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Product Issues
FAULTY OXYGEN EQUIPMENT
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
GASTROINTESTINAL REFLUX
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
GROUND LEVEL FALL
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
HEMATOCHEZIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Vascular disorders
HEMATOMA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Renal and urinary disorders
HEMATURIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.49%
3/607 • Up to the 90 day visit
|
|
Eye disorders
HORSESHOE TEAR OF RETINA WITHOUT DETACHMENT
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Vascular disorders
HYPERTENSION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
INFLUENZA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
IRRITABLE BOWL SYNDROME
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
LEFT ARM PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
LEFT LOWER EXTREMITY PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
LEFT PLEURITIC CHEST PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
LOWER EXTREMITY PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
MILD LEFT SYSTOLIC DYSFUNCTION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
MOTOR VEHICLE ACCIDENT
|
0.00%
0/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
MOTOR VEHICLE VS PEDESTRIAN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Nervous system disorders
NON-INTRACTABLE HEADACHE
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Vascular disorders
NON-OCCLUSIVE THROMBUS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
OTITIS MEDIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Cardiac disorders
PALPITATIONS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Cardiac disorders
PAROXYSMAL A-FIB
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Vascular disorders
PARTIAL MURAL THROMBUS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
PERIVASCULAR DERMATITIS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.33%
2/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC CHEST PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Infections and infestations
PNEUMONIA
|
0.33%
2/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
POST ACUTE COVID-19 SYMPTOMS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
POST ACUTE COVID-19 SYNDROME
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Surgical and medical procedures
POWER FLOW PORT EVALUATION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
PRURITIC RASH
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Renal and urinary disorders
RENAL CALCULI
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
RESOLVING COVID-19 PNEUMONIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS FLARE UP
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
RIGHT HAND ABSCESS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
RIGHT LEG PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
RIGHT LOWER EXTREMITY PAIN
|
0.33%
2/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
RIGHT RING FINGER LACERATION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
General disorders
SUBSTERNAL CHEST PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
SUPERFICIAL GUN SHOT WOUND
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
SUPERIOR LABRAL TEAR
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
TELOGEN EFFLUVIUM
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Injury, poisoning and procedural complications
TRIQUETRUM FRACTURE
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
TYPE II NSTEMI
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Metabolism and nutrition disorders
UNCONTROLLED DIABETES
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.16%
1/610 • Up to the 90 day visit
|
0.33%
2/607 • Up to the 90 day visit
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/610 • Up to the 90 day visit
|
0.49%
3/607 • Up to the 90 day visit
|
|
Nervous system disorders
VASOVAGAL SYNCOPE
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
VIRAL SYNDROME
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
General disorders
WEAKNESS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
WORSENING BACK PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
General disorders
WORSENING CHEST PAIN
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Cardiac disorders
WORSENING CORONARY ARTERY DISEASE
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Infections and infestations
WORSENING COVID-19 PNEUMONIA
|
0.49%
3/610 • Up to the 90 day visit
|
0.82%
5/607 • Up to the 90 day visit
|
|
Gastrointestinal disorders
WORSENING DENTAL PAIN
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Skin and subcutaneous tissue disorders
WORSENING DIABETIC FOOT ULCER
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Nervous system disorders
WORSENING HAND TREMOR
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
WORSENING HYPOXIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Respiratory, thoracic and mediastinal disorders
WORSENING INTERSTITIAL LUNG DISEASE
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Musculoskeletal and connective tissue disorders
WORSENING MOREL LAVALLEE LESION
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
|
Renal and urinary disorders
WORSENING NEPHROLITHIASIS
|
0.00%
0/610 • Up to the 90 day visit
|
0.16%
1/607 • Up to the 90 day visit
|
|
Infections and infestations
WORSENING PNEUMONIA
|
0.16%
1/610 • Up to the 90 day visit
|
0.82%
5/607 • Up to the 90 day visit
|
|
Eye disorders
WORSENING VISION LOSS
|
0.16%
1/610 • Up to the 90 day visit
|
0.00%
0/607 • Up to the 90 day visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place