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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,000
- 主要终点
- Percentage of time in the therapeutic range (TTR) for tecarfarin vs. warfarin for each treatment group in the randomized population
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: tecarfarin (Drug)
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.
干预措施: Warfarin (Drug)
结局指标
主要结局
Percentage of time in the therapeutic range (TTR) for tecarfarin vs. warfarin for each treatment group in the randomized population
时间窗: 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
次要结局
- Percentage of patients with INR > 5.0(From the date of randomization until study termination, up to 24 months (1st month not included))
- 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))
- 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))
- Time to first embolic event for tecarfarin vs. warfarin(From the date of randomization until study termination, up to 24 months)
- 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))