NCT02522221

Tecarfarin Anti-Coagulation Trial (TACT)

A "Real-World", Randomized, Open-Label, Study on the Efficacy, Safety, and Tolerability of Tecarfarin (ATI-5923) a Novel Vitamin K Antagonist, Versus Warfarin in Subjects Requiring Chronic Anticoagulation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Espero Biopharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

TACT is a "real world" randomized controlled trial of tecarfarin, a novel vitamin K antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two groups of subjects who require chronic oral anticoagulation for a broad panel of indications.

Detailed description

This will be a randomized, parallel-arm, open-label study comparing the safety and efficacy of tecarfarin and warfarin in approximately 1000 subjects who have an indication for chronic oral anticoagulation. The study will be fully enriched with subjects who are taking at least one CYP2C9-interacting medication and have either chronic kidney disease stage 3 or 4 and/or a genetic variant allele for CYP2C9. The study will be conducted at approximately 140 sites with experience in the management of anticoagulation subjects. Eligible subjects will be randomized to receive either tecarfarin or warfarin for a period ranging from 6 months to a maximum of approximately 24 months.

Conditions

• Thromboembolism
• Thrombosis

Interventions

Type	Name	Description
DRUG	Warfarin	Warfarin is an oral vitamin K antagonist anticoagulant.
DRUG	tecarfarin	Tecarfarin is an oral vitamin K antagonist anticoagulant

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-03-30
• Completion: 2019-07-01
• First posted: 2015-08-13
• Last updated: 2018-01-25

Regulatory

• FDA-regulated drug study