Trial Outcomes & Findings for Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment (NCT NCT04435769)
NCT ID: NCT04435769
Last Updated: 2023-02-08
Results Overview
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \>=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
COMPLETED
109 participants
Baseline (from retrospective data retrieved in the study)
2023-02-08
Participant Flow
Data from eligible participants with non-valvular atrial fibrillation (NVAF) who started treatment with warfarin or apixaban for the prevention of a secondary stroke or transient ischemic attack (TIA) between 2009 to 2019 were observed in this study. Participants' records were retrieved and observed only for first 6 months of the warfarin/apixaban treatment. Collected data from all the participants were observed approximately for 10 months in this observational study.
Participant milestones
| Measure |
Apixaban
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
67
|
|
Overall Study
Full Analysis Set (FAS)
|
42
|
67
|
|
Overall Study
Per Protocol (PP) Population
|
40
|
63
|
|
Overall Study
COMPLETED
|
42
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.1 Years
STANDARD_DEVIATION 12.1 • n=40 Participants
|
79.5 Years
STANDARD_DEVIATION 9.3 • n=63 Participants
|
79.0 Years
STANDARD_DEVIATION 10.4 • n=103 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=40 Participants
|
34 Participants
n=63 Participants
|
51 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=40 Participants
|
29 Participants
n=63 Participants
|
52 Participants
n=103 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body-Mass Index (BMI)
|
26.9 Kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 4.8 • n=40 Participants
|
28.7 Kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 5.4 • n=63 Participants
|
28.0 Kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 5.2 • n=103 Participants
|
|
Duration from index event to the initiation of non-vitamin K antagonist anticoagulant therapy (NOAC)
|
11.8 Days
STANDARD_DEVIATION 12.7 • n=40 Participants
|
10.0 Days
STANDARD_DEVIATION 6.2 • n=63 Participants
|
10.7 Days
STANDARD_DEVIATION 9.2 • n=103 Participants
|
|
Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy
Aspirin
|
19 Participants
n=40 Participants
|
35 Participants
n=63 Participants
|
54 Participants
n=103 Participants
|
|
Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy
Clopidogrel
|
11 Participants
n=40 Participants
|
8 Participants
n=63 Participants
|
19 Participants
n=103 Participants
|
|
Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy
Thrombolytics
|
15 Participants
n=40 Participants
|
9 Participants
n=63 Participants
|
24 Participants
n=103 Participants
|
|
Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy
Clexane
|
18 Participants
n=40 Participants
|
26 Participants
n=63 Participants
|
44 Participants
n=103 Participants
|
|
Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy
Fraxiparine
|
14 Participants
n=40 Participants
|
19 Participants
n=63 Participants
|
33 Participants
n=103 Participants
|
|
Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy
Low molecular weight heparin (LMWH) - preventive dose
|
18 Participants
n=40 Participants
|
33 Participants
n=63 Participants
|
51 Participants
n=103 Participants
|
PRIMARY outcome
Timeframe: Baseline (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \>=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
CHA2-DS2-VASc Score at Baseline
|
4.6 Units on a scale
Standard Deviation 1.5
|
4.3 Units on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \>=3 = high risk of bleed.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
HAS-BLED Score at Baseline
|
2.7 Units on a scale
Standard Deviation 1.2
|
2.5 Units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Month 6 (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \>=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
CHA2-DS2-VASc Score at Month 6
|
5.0 Units on a scale
Standard Deviation 1.4
|
4.9 Units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Month 6 (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \>=3 = high risk of bleed.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
HAS-BLED Score at Month 6
|
3.1 Units on a scale
Standard Deviation 1.1
|
2.8 Units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
0 visit
|
55.0 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
1 visit
|
32.5 Percentage of participants
|
36.5 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
2 visits
|
12.5 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
3 visits
|
0.0 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
4 visits
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
5 visits
|
0.0 Percentage of participants
|
1.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna \[CZK\] per visit). Costs were calculated based on the number of outpatient visits during the treatment.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of Outpatient Visits During First 6 Months of Treatment
|
258.8 Czech koruna
Standard Deviation 320.4
|
414.3 Czech koruna
Standard Deviation 525.7
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (\>=) 20.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
>=20
|
0.0 Percentage of participants
|
49.2 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
0
|
97.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
1 to 9
|
2.5 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
10 to 19
|
0.0 Percentage of participants
|
46.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of INR Measurements During First 6 Months of Treatment
|
5.3 Czech koruna
Standard Deviation 33.7
|
4003.0 Czech koruna
Standard Deviation 1230.2
|
PRIMARY outcome
Timeframe: Baseline (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Dosage of Warfarin and Apixaban at the Initiation of the Treatment
|
7.5 Milligrams per day
Standard Deviation 2.5
|
5.9 Milligrams per day
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Dosage of Warfarin and Apixaban During First 6 Months of Treatment
|
7.4 Milligrams per day
Standard Deviation 2.5
|
4.6 Milligrams per day
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of Medication During First 6 Months of Treatment
|
8551.0 Czech koruna
Standard Deviation 2932.5
|
1263.5 Czech koruna
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Categorized According to Number of Hospital Admissions
0
|
95.0 Percentage of participants
|
81.0 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Hospital Admissions
1
|
2.5 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Hospital Admissions
2
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Categorized According to Number of Hospital Admissions
3
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of Hospital Admissions During First 6 Months of Treatment
|
2777.5 Czech koruna
Standard Deviation 13820.1
|
12326.8 Czech koruna
Standard Deviation 43596.2
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: Data collected by trial sites for diagnostic procedures were incorrect, hence data was not evaluated and analyzed for this outcome measure.
In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment
Cardiac ischemia
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment
Stroke/TIA
|
0.0 Percentage of participants
|
9.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of Ischemic Events During First 6 Months of Treatment
|
684.8 Czech koruna
Standard Deviation 4331.2
|
5386.6 Czech koruna
Standard Deviation 16735.9
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
|
2.5 Percentage of participants
|
3.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
GI bleeding
|
0.0 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
Muscle hematomas
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
Epistaxis
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
Other- Intraparenchymal hematoma of the lower lobe
|
0.0 Percentage of participants
|
1.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of Major Hemorrhagic Events During First 6 Months of Treatment
|
2092.7 Czech koruna
Standard Deviation 13235.4
|
2657.4 Czech koruna
Standard Deviation 14793.8
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
|
1285.1 Czech koruna
Standard Deviation 5697.5
|
1666.7 Czech koruna
Standard Deviation 10157.1
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Number of Participants With Other Adverse Events During First 6 Months of Treatment
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Cost of Other Adverse Events During First 6 Months of Treatment
|
2063.9 Czech koruna
Standard Deviation 9628.8
|
1328.7 Czech koruna
Standard Deviation 10546.2
|
PRIMARY outcome
Timeframe: Up to first 6 months of treatment (from retrospective data retrieved in the study)Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
In this outcome measure, percentage of participants who died due to the given treatment were reported.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=63 Participants
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
|
0.0 Percentage of participants
|
1.6 Percentage of participants
|
Adverse Events
Apixaban
Warfarin
Serious adverse events
| Measure |
Apixaban
n=42 participants at risk
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=67 participants at risk
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
General disorders
Cardiac ischemia
|
2.4%
1/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
0.00%
0/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Stroke/TIA
|
0.00%
0/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
9.0%
6/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Intracranial bleeding
|
2.4%
1/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
3.0%
2/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
GI bleeding
|
0.00%
0/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
1.5%
1/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Intraparenchymal hematoma of the lower lobe
|
0.00%
0/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
1.5%
1/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Diarrhoea
|
0.00%
0/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
1.5%
1/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Death
|
0.00%
0/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
1.5%
1/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
Other adverse events
| Measure |
Apixaban
n=42 participants at risk
Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
Warfarin
n=67 participants at risk
Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.
|
|---|---|---|
|
General disorders
Epistaxis
|
2.4%
1/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
0.00%
0/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Muscle hematomas
|
2.4%
1/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
0.00%
0/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Feeling sick
|
2.4%
1/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
0.00%
0/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Headache
|
2.4%
1/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
0.00%
0/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
|
General disorders
Vertigo
|
2.4%
1/42 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
0.00%
0/67 • 6 Months (from retrospective data retrieved in the study)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER