REACTIC-TAVI Trial: Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation. A Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of treatment in suppressing High Platelet Reactivity
研究概览
简要总结
The narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. To correct this problem, many patients undergo Transcatheter Aortic Valve Implantation (TAVI) according to standard clinical practice. Patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. This treatment is not yet well established. Current guidelines recommend dual antiplatelet therapy with Aspirin and Clopidogrel for 3-6 months after TAVI to avoid thromboembolic complications. But the risk of bleeding events with DAPT in this population is not negligible.
This study aims to determine the degree of response to Ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with Clopidogrel 75mg every 24 hours. The study will evaluate if patients have an adequate response to Clopidogrel and if not, then patients will start treatment with Ticagrelor 60 mg every 12 hours after TAVI and until completing 3 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with severe symptomatic aortic stenosis
- •Accepted for transfemoral TAVI by a Heart Team decision
- •Evaluation of platelet reactivity assessed by VerifyNow® assay prior TAVI
排除标准
- •Contraindication to TAVI
- •TAVI performed by a different access route than transfemoral
- •Ned for oral anticoagulation therapy
- •History of intracranial hemorrhage
- •Ischemic stroke the 14 days before TAVI
- •Active pathological bleeding or diathesis
- •Moderate to severe hepatic impairment
- •Use of strong CYP34A inhibitors or inducers
- •Contraindications to DAPT for 3 months
- •Contraindication to clopidogrel or ticagrelor
- •Platelet count <50,000
- •Pregnancy or breastfeeding
研究组 & 干预措施
Ticagrelor 60 mg
Platelet reactivity will be assessed by VerifyNow P2Y12 assay in ALL enrolled patients after confirmed use of clopidogrel for 4 days prior TAVI. Patients that have not completed a pre-treatment period of 4 days of clopidogrel will receive a loading dose of 300mg, according to the clinical practice, with assessment of platelet reactivity by VerifyNow P2Y12 at the following 6 hours. Based on results of basal VerifyNow P2Y12 assay at least 24 hrs before the index-TAVI procedure, patients with:
High on-treatment platelet reactivity (PRU ≥ 160 assessed with VerifyNow P2Y12 assay): Patients will be switched to receive ticagrelor 60mg twice daily initiating at least 24 hours before TAVI procedure, in order to arrive to the index TAVI procedure with at least two doses of 60 mg, and will continue with Ticagrelor 60mg twice per day during the following three months.
干预措施: Ticagrelor 60mg (Drug)
结局指标
主要结局
Efficacy of treatment in suppressing High Platelet Reactivity
时间窗: 90 ± 7 days post TAVI
Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.
次要结局
- Security: incidence of hemorrhagic complications(120 ± 7 days post TAVI)
研究者
Andres Iñiguez Romo
MD, phD
Fundacin Biomedica Galicia Sur