Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
研究概览
简要总结
This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.
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
- •Patients aged 18-85 years old with severe aortic stenosis;
- •Successful TAVR via femoral artery approach (VARC 3 device success criteria);
- •Implantation of self-expanding bioprosthetic valve;
- •Be willing to give informed consent.
排除标准
- •Patients with anticoagulant indications, such as atrial fibrillation, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism, history of mechanical valve implantation;
- •Patients needed double antiplatelet therapy, such as acute myocardial infarction within one year, coronary stent implantation within 6 months, peripheral artery stent implantation within 3 months;
- •Patients who received concomitant TAVR and percutaneous coronary intervention;
- •Patients with peptic ulcers or active bleeding or history of cerebral hemorrhage
- •Patients with ischemic stroke or TIA within 6 months;
- •Patients with left ventricular ejection fraction < 30% or pulmonary hypertension (>70mmHg) before discharge;
- •Patients intolerant or allergic to aspirin or Vitamin-K antagonists (warfarin);
- •Patients with evaluated glomerular filtration rate <15ml/min/m2 (Cockcroft formula) or on dialysis;
- •Patients with poor compliance, unable to complete the study and follow-up as required;
- •Patients' life expectancy less than 1 year;
- •Patients who already participated in other clinical trials (within the last 30 days).
研究组 & 干预措施
Oral anticoagulation therapy group
Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5
干预措施: Oral anticoagulation therapy (Drug)
Single antiplatelet therapy group
Aspirin, 75-100mg
干预措施: Single antiplatelet therapy (Drug)
结局指标
主要结局
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
时间窗: 1 year
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Rates of bioprosthetic valve thrombosis detected by 4D-CT
时间窗: 1 year
次要结局
- Bleeding (BRAC 1, 2, 3a-c, 5)(1 year)
- All-cause mortality(1 year)
- Peripheral artery thrombosis(1 year)
- A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis(1 year)
- Myocardial infarction(1 year)
- Stroke(1 year)
- Major bleeding (BARC 3a)(1 year)
- Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)(1 year)
- Cardiac death(1 year)
- Minor bleeding (BRAC 2)(1 year)
- Disabling/life-threatening bleeding (BARC 3b,3c,5)(1 year)
- TIA(1 year)
- Intracardiac thrombosis(1 year)
研究者
Yongjian Wu, MD, PhD
Director of coronary artery disease center
China National Center for Cardiovascular Diseases