Trial Outcomes & Findings for Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data (NCT NCT05256797)

NCT ID: NCT05256797

Last Updated: 2025-03-04

Results Overview

Claims-based algorithm: incidence of major bleeding or clinically relevant non-major bleeding events

• Recruitment status: COMPLETED
• Target enrollment: 353980 participants
• Primary outcome timeframe: Through study completion or censoring, up to 365 days
• Results posted on: 2025-03-04

Participant Flow

Participant milestones

Measure	Rivaroxaban Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Overall Study STARTED	176990	176990
Overall Study COMPLETED	176990	176990
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data

Baseline characteristics by cohort

Measure	Rivaroxaban n=176 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group	Total n=353980 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26,276 Participants n=5 Participants	26,331 Participants n=7 Participants	52607 Participants n=5 Participants
Age, Categorical >=65 years	150,714 Participants n=5 Participants	150,659 Participants n=7 Participants	301373 Participants n=5 Participants
Age, Continuous	73.91 years STANDARD_DEVIATION 9.65 • n=5 Participants	73.88 years STANDARD_DEVIATION 9.75 • n=7 Participants	73.90 years STANDARD_DEVIATION 9.70 • n=5 Participants
Sex: Female, Male Female	88,058 Participants n=5 Participants	88,018 Participants n=7 Participants	176076 Participants n=5 Participants
Sex: Female, Male Male	88,932 Participants n=5 Participants	88,972 Participants n=7 Participants	177904 Participants n=5 Participants
Race/Ethnicity, Customized White	127,937 Participants n=5 Participants	127,949 Participants n=7 Participants	255886 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2,554 Participants n=5 Participants	2,554 Participants n=7 Participants	5108 Participants n=5 Participants
Race/Ethnicity, Customized Black	7,016 Participants n=5 Participants	7,011 Participants n=7 Participants	14027 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4,140 Participants n=5 Participants	4,162 Participants n=7 Participants	8302 Participants n=5 Participants
Race/Ethnicity, Customized North American Native	326 Participants n=5 Participants	332 Participants n=7 Participants	658 Participants n=5 Participants
Race/Ethnicity, Customized Other	1,283 Participants n=5 Participants	1,283 Participants n=7 Participants	2566 Participants n=5 Participants
Race/Ethnicity, Customized Unknown/Missing	2,830 Participants n=5 Participants	2,792 Participants n=7 Participants	5622 Participants n=5 Participants
Race/Ethnicity, Customized N/A	30,904 Participants n=5 Participants	30,907 Participants n=7 Participants	61811 Participants n=5 Participants
Region of Enrollment United States	176,990 participants n=5 Participants	176,990 participants n=7 Participants	353980 participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion or censoring, up to 365 days

Population: Propensity score matched population across 3 databases

Claims-based algorithm: incidence of major bleeding or clinically relevant non-major bleeding events

Outcome measures

Measure	Rivaroxaban n=176990 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176990 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding Events	9.2 No. of new events per 100 person-years Interval 9.0 to 9.5	6.4 No. of new events per 100 person-years Interval 6.2 to 6.6

SECONDARY outcome

Timeframe: Through study completion or censoring, up to 365 days

Population: Propensity score matched population across 3 databases

Claims-based algorithm: Incidence of major bleeding

Outcome measures

Measure	Rivaroxaban n=176990 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176990 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Incidence of Major Bleeding	4.0 No. of new events per 100 person-years Interval 3.8 to 4.1	2.4 No. of new events per 100 person-years Interval 2.3 to 2.5

SECONDARY outcome

Timeframe: Through study completion or censoring, up to 365 days

Population: Propensity score matched population across 3 databases

Claims-based algorithm: Incidence of clinically relevant non-major bleeding

Outcome measures

Measure	Rivaroxaban n=176990 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176990 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Incidence of Clinically Relevant Non-major Bleeding	8.7 No. of new events per 100 person-years Interval 8.4 to 8.9	5.9 No. of new events per 100 person-years Interval 5.8 to 6.1

SECONDARY outcome

Timeframe: Through study completion or censoring, up to 365 days

Population: Propensity score matched population across 3 databases

Claims-based algorithm: Incidence of all-cause mortality

Outcome measures

Measure	Rivaroxaban n=176990 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176990 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Incidence of All-cause Mortality	2.7 No. of new events per 100 person-years Interval 2.6 to 2.8	2.4 No. of new events per 100 person-years Interval 2.3 to 2.5

SECONDARY outcome

Timeframe: Through study completion or censoring, up to 365 days

Population: Propensity score matched population across 3 databases

Claims-based algorithm: Incidence of stroke

Outcome measures

Measure	Rivaroxaban n=176990 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176990 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Incidence of Stroke	1.1 No. of new events per 100 person-years Interval 1.0 to 1.2	0.9 No. of new events per 100 person-years Interval 0.8 to 1.0

SECONDARY outcome

Timeframe: Through study completion or censoring, up to 365 days

Population: Propensity score matched population across 3 databases

Claims-based algorithm: Incidence of extracranial bleeding (any position)

Outcome measures

Measure	Rivaroxaban n=176990 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176990 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Incidence of Extracranial Bleeding	3.6 No. of new events per 100 person-years Interval 3.5 to 3.8	2.1 No. of new events per 100 person-years Interval 2.0 to 2.2

SECONDARY outcome

Timeframe: Through study completion or censoring, up to 365 days

Population: Propensity score matched. population across 3 databases

Claims-based algorithm: Incidence of intracranial bleeding (any position)

Outcome measures

Measure	Rivaroxaban n=176990 Participants Reference group Rivaroxaban: Any rivaroxaban dispensing claim is used as the reference group	Apixaban n=176990 Participants Exposure group Apixaban: Any apixaban dispensing claim is used as the exposure group
Incidence of Intracranial Bleeding	0.4 No. of new events per 100 person-years Interval 0.3 to 0.4	0.3 No. of new events per 100 person-years Interval 0.3 to 0.4

Adverse Events

Rivaroxaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1958 deaths

Apixaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1840 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shirley Wang

Brigham and Women's Hospital

Phone: 617-525-8376

Email: swang1@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place