Tecarfarin Anti-Coagulation Trial (TACT)
- Registration Number
- NCT02522221
- Lead Sponsor
- Espero Biopharma
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tecarfarin tecarfarin Tecarfarin will be administered and dose adjusted by the investigator. Dose adjustments will be made in accordance with a target INR range pre-specified by the investigator. Warfarin Warfarin Warfarin will be administered and dose adjusted by the investigator. Dose adjustments will be made in accordance with a target INR range pre-specified by the investigator.
- Primary Outcome Measures
Name Time Method Percentage of time in the therapeutic range (TTR) for tecarfarin vs. warfarin for each treatment group in the randomized population From the date of randomization until study termination, up to 24 months (1st month not included) Interpolated and observed TTR will be calculated for the two treatment groups
- Secondary Outcome Measures
Name Time Method Percentage of patients with INR > 5.0 From the date of randomization until study termination, up to 24 months (1st month not included) Percentage of observations of patients with INR \> 5.0 will be calculated for the two treatment groups
Percentage TTR for tecarfarin vs warfarin for the sub-population of patients who are taking a CYP2C9-interacting medication and have chronic kidney disease stage 3 or 4 (eGFR ≥ 15 to <60 mL/min/1.73 m2) From the date of randomization until study termination, up to 24 months (1st month not included) Interpolated and observed TTR will be calculated for the two treatment groups
Percentage of patients with INR > 4.0 for tecarfarin vs. warfarin From the date of randomization until study termination, up to 24 months (1st month not included) Percentage of observations of patients with INR \> 4.0 will be calculated for the two treatment groups
Time to first embolic event for tecarfarin vs. warfarin From the date of randomization until study termination, up to 24 months Time from enrollment until any embolic event (CVA, pulmonary embolism, peripheral embolism) while enrolled will be calculated for the two groups
Percentage TTR for tecarfarin vs. warfarin in the sub-population of patients who are taking a CYP2C9-interacting medication and have a CYP2C9 genotype variant allele From the date of randomization until study termination, up to 24 months (1st month not included) Interpolated and observed TTR will be calculated for the two treatment groups