Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

Phase 4

Terminated

• Conditions: Venous Thromboembolism
• Interventions: Drug: Apixaban 2.5 MG; Drug: Rivaroxaban 10 MG; Drug: Warfarin

• Registration Number: NCT03196349
• Lead Sponsor: Duke University

Brief Summary

Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.

Detailed Description

Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Study Start: 2018-08-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Results First Submitted: 2019-07-26
• Results First Submitted QC: 2019-07-26
• Results First Posted: 2019-08-14
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apixaban	Apixaban 2.5 MG	Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily
Rivaroxaban	Rivaroxaban 10 MG	Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily
Warfarin	Warfarin	Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Clinically Relevant Bleeding Events	Randomization to 12 months	Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))
Number of Subjects With Recurrent Venous Thromboembolism (VTE)	Randomization to 12 months	Primary efficacy outcome of recurrent VTE

Trial Locations

Locations (1)

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States