EUCTR2019-004860-23-ES进行中（未招募）1 期
REACTIC-TAVI TRIAL: Platelet REACtivity according to TICagrelor dose after Trancathter Aortic Valve Implantation. A pilot study. - Ticagrelor 60 mg BID after TAVI
Andres Iñiguez Romo0 个研究点目标入组 40 人开始时间: 2020年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- >18 years old
- •- Diagnosed with severe aortic stenosis
- •- High and/or intermediate surgery risk based on current risk scores
- •- Ruled in by a Heart Team decision
- •- Without previous dual antiplatelet therapy
- •- Plaqueted reactivity made by VerifyNow® assays in whom has been treated with Clopidogrel
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Contraindication to TAVI
- •- Atrial Fibrillation (which needs oral anticoagulation)
- •- Oral anticoagulation
- •- 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
- •- Use of ISRS (Paroxetina, Sertralina, Citalopram)
- •- Contraindications to DAPT for 3 months
- •- Contraindication to Aspirin, clopidogrel or ticagrelor
- •- Platelet count <50.000
- •- Pregnancy or breastfeeding
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