EUCTR2021-001534-19-FR进行中（未招募）1 期
Direct oral Anticoagulants for Prevention of lEft ventRIcular Thrombus after anterior acute myocardial InFarction - APERITIF
AP-HP/DRCI0 个研究点目标入组 560 人开始时间: 2021年3月25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
- 560
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
- •-Age = 18 years;
- •-Anterior STEMI (e.g., ST elevation above the J-point of =0.1 millivolt in =two contiguous leads or left bundle branch block) or very high-risk NSTEMI (e.g., dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias) with echographic evidence of anterior wall motion abnormalities and, with a culprit lesion of the proximal or mid portion of the left anterior descending (LAD) on the coronary angiography;
- •-No contraindication to CMR (e.g., claustrophobia, pacemaker or defibrillator not compatible);
- •-Ability to provide written informed consent and willing to participate in 1-month follow-up period.
- •-Affiliation of social security regime.
- •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
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with cardiogenic shock (systolic blood pressure <90 mmHg with clinical signs of low output or patients requiring inotropic agents);
- •-Patients referred to surgery for coronary artery bypass grafting (CABG) or treatment of acute complications (e.g. ventricular septal rupture);
- •-Patients treated with fibrinolytic therapy;
- •-LV thrombus diagnosed before randomization using a transthoracic echocardiography;
- •-Active major bleeding or major surgery within the last 30 days;High bleeding risk (patients considered at increased risk of bleeding during DAPT; e.g. PRECISE-DAPT score >25; severe liver failure or Child Pugh class C);
- •-Known history of intracranial hemorrhagic stroke or intra-cranial aneurysm;
- •-Known history of peptic ulcer;
- •-Known stroke (any type) within the last 30 days;
- •-Known intolerance to aspirin, P2Y12 inhibitors, rivaroxaban and their excipients;
- •-According to the SmPC any contraindication to rivaroxaban, aspirin, clopidogrel, ticagrelor, and prasugrel
- •-Known intolerance to gadolinium chelates;
- •-Chronic kidney disease (creatinine clearance (ClCr) <30 mL/min);
- •-Indication for anticoagulation (e.g. atrial fibrillation, mechanical valves, LV thrombus…);
- •-Life expectancy <1 month;
- •-Known pregnancy at time of randomization or breastfeeding women;
- •-Currently participating in another trial
- •-Protected adults (including individual under guardianship by court order)
- •-Persons deprived of their liberty by judicial or administrative decision
研究者
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