NCT03196349

Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Warfarin	Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3
DRUG	Apixaban 2.5 MG	Will be randomized to receive open label apixaban of 2.5 mg twice daily
DRUG	Rivaroxaban 10 MG	Will be randomized to receive open label rivaroxaban of 10mg daily

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2017-06-22
• Last updated: 2019-12-13
• Results posted: 2019-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study