Trial Outcomes & Findings for Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (NCT NCT03196349)

NCT ID: NCT03196349

Last Updated: 2019-12-13

Results Overview

Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 44 participants
• Primary outcome timeframe: Randomization to 12 months
• Results posted on: 2019-12-13

Participant Flow

Participant milestones

Measure	Warfarin Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Overall Study STARTED	17	14	13
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	17	14	13

Reasons for withdrawal

Measure	Warfarin Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Overall Study Did not receive study drug	0	1	2
Overall Study No data entered	2	4	0
Overall Study Study Terminated early	15	9	11

Baseline Characteristics

In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.

Baseline characteristics by cohort

Measure	Warfarin n=16 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=13 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=12 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=16 Participants	5 Participants n=13 Participants	11 Participants n=12 Participants	27 Participants n=41 Participants
Age, Categorical >=65 years	5 Participants n=16 Participants	8 Participants n=13 Participants	1 Participants n=12 Participants	14 Participants n=41 Participants
Sex: Female, Male Female	4 Participants n=16 Participants	3 Participants n=13 Participants	2 Participants n=12 Participants	9 Participants n=41 Participants
Sex: Female, Male Male	12 Participants n=16 Participants	10 Participants n=13 Participants	10 Participants n=12 Participants	32 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=12 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=11 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=39 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Race (NIH/OMB) Asian	0 Participants n=16 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=12 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	1 Participants n=11 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	1 Participants n=39 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=12 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=11 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=39 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Race (NIH/OMB) Black or African American	2 Participants n=16 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	1 Participants n=12 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	2 Participants n=11 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	5 Participants n=39 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Race (NIH/OMB) White	14 Participants n=16 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	10 Participants n=12 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	8 Participants n=11 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	32 Participants n=39 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Race (NIH/OMB) More than one race	0 Participants n=16 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=12 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=11 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=39 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	1 Participants n=12 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	0 Participants n=11 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.	1 Participants n=39 Participants • In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Region of Enrollment United States	10 participants n=16 Participants	7 participants n=13 Participants	9 participants n=12 Participants	26 participants n=41 Participants
Region of Enrollment Canada	6 participants n=16 Participants	6 participants n=13 Participants	3 participants n=12 Participants	15 participants n=41 Participants

PRIMARY outcome

Timeframe: Randomization to 12 months

Population: 44 subjects were randomized but analysis was only done on participants that had started therapy by the 1 month telephone visit

Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))

Outcome measures

Measure	Warfarin n=14 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=8 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=9 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Number of Subjects With Clinically Relevant Bleeding Events	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Randomization to 12 months

Primary efficacy outcome of recurrent VTE

Outcome measures

Measure	Warfarin n=17 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=14 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=13 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Number of Subjects With Recurrent Venous Thromboembolism (VTE)	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 12 months

Major bleeding

Outcome measures

Measure	Warfarin n=17 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=14 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=13 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Number of Subjects Experiencing Major Bleeding	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 12 months

Clinically relevant non-major bleeding

Outcome measures

Measure	Warfarin n=17 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=14 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=13 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Number of Subjects Experiencing Clinically Relevant Non-major Bleeding	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 12 months

Premature termination of study medication

Outcome measures

Measure	Warfarin n=17 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=14 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=13 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Number of Subjects With Premature Termination of Study Medication	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 12 months

All cause mortality

Outcome measures

Measure	Warfarin n=17 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=14 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=13 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Number of Subjects Experiencing All-cause Mortality	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 12 months

MI, ischemic stroke, peripheral arterial embolism

Outcome measures

Measure	Warfarin n=17 Participants Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Apixaban n=14 Participants Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily	Rivaroxaban n=13 Participants Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily
Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)	1 Participants	0 Participants	0 Participants

Adverse Events

Warfarin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Apixaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rivaroxaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Ortel

Duke University

Phone: 919-684-5350 ext 3

Email: thomas.ortel@duke.edu

Results disclosure agreements

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