NCT07677410招募中不适用
Prospective, Multicenter, Randomized Controlled Trial Evaluating the Safety and Efficacy of Different Antithrombotic Therapy Strategies in Patients With Severe Aortic Regurgitation Undergoing Transcatheter Aortic Valve Replacement
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 1,172 人开始时间: 2026年7月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,172
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced Non-hierarchical Composite Endpoint
研究概览
简要总结
This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation. Patients are randomized 1:1 to aspirin 75-100 mg daily for 12 months versus warfarin (INR 2-3) for 6 months followed by aspirin for 6 months. Primary hypothesis: aspirin is superior for bleeding and non-inferior for death/thrombosis. Primary endpoint is a composite of death, stroke, thrombosis, MI, embolism, and major bleeding at 1 year. Sample size: 1172. Follow-up: 30 days, 6 months, 12 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
- Single (Outcomes Assessor)
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
- •Age ≥18 years.
- •Patients with severe aortic regurgitation (AR) who achieve technical success after TAVR using devices specifically indicated for AR (per VARC-3 criteria).
- •Trileaflet aortic valve anatomy.
- •No long-term anticoagulation indication (including but not limited to: atrial fibrillation, mechanical mitral valve prosthesis, deep vein thrombosis, pulmonary embolism, left ventricular thrombus, pulmonary hypertension, or coagulation disorders) as confirmed by the investigator.
- •Signed written informed consent and willingness to comply with randomization, study procedures, and follow-up.
排除标准
- •Need for oral anticoagulation or dual antiplatelet therapy, or need for oral or intravenous strong CYP3A inhibitors that cannot be paused during the study period.
- •Active pathological bleeding, subdural hematoma, or history of intracranial hemorrhage.
- •Ischemic stroke within 30 days before TAVR.
- •Acute myocardial infarction within 30 days.
- •Severe hepatic insufficiency (cirrhosis, hepatic decompensation).
- •Severe renal insufficiency (eGFR < 30 mL/min/1.73 m²) or need for renal replacement therapy.
- •Stent implantation (including coronary, carotid, or peripheral arteries) within 12 months before TAVR, or planned stent implantation within 1 year after TAVR.
- •Coronary artery bypass grafting (CABG) within 12 months before TAVR.
- •Allergy, intolerance, or known resistance to aspirin, clopidogrel, or warfarin.
- •Known coagulation disorders or bleeding diathesis (including but not limited to platelet count ≤50,000/mm³ at screening).
- •Any contraindication to anticoagulation therapy.
- •Prior aortic valve prosthesis (mechanical or bioprosthetic); mitral valve bioprosthesis replacement within 1 year before TAVR; or prior mitral mechanical valve replacement; or prior tricuspid valve replacement.
- •Emergency TAVR with cardiogenic shock manifesting as low cardiac output, vasopressor or respiratory dependence, or mechanical hemodynamic support.
- •Life expectancy <1 year (e.g., terminal malignancy).
- •Participation in another investigational drug or device clinical study (patients who have completed the primary endpoint of the study and are currently in long-term follow-up are not excluded).
- •Pregnancy or planned pregnancy, or use of estrogen or estrogen-like drugs (for women with suspected pregnancy, serum or urine human chorionic gonadotropin test must be negative before enrollment).
- •Any other condition deemed by the investigator to be inappropriate for study participation.
研究组 & 干预措施
Aspirin Monotherapy
Experimental
Aspirin 75-100 mg orally once daily for 12 months
干预措施: Aspirin (Drug)
Standard Therapy
Active Comparator
Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months
干预措施: Warfarin (Drug)
Standard Therapy
Active Comparator
Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months
干预措施: Aspirin (Drug)
结局指标
主要结局
Number of Participants Who Experienced Non-hierarchical Composite Endpoint
时间窗: 12 months post-procedure
The primary endpoint is a non-hierarchical composite endpoint including all-cause death, stroke, prosthetic valve thrombosis, intracardiac thrombosis, myocardial infarction, deep vein thrombosis or pulmonary embolism, systemic embolism, and life-threatening, disabling, or major bleeding (VARC-3 definition).
次要结局
- Number of Participants Who Experienced Aortic Valve Re-Intervention(12 months post-procedure)
- Number of Participants Who Experienced Composite Endpoint of All-Cause Death, Ischemic Stroke, Valve/Intracardiac Thrombosis, and Myocardial Infarction.(12 months post-procedure)
- Number of Participants Who Experienced Composite of Life-threatening, Disabling, or Major Bleeding (based on VARC-3 criteria Type 2-4)(12 months post-procedure)
- Number of Participants Who Experience Composite of Cardiovascular Death, Major Bleeding, Stroke, and Myocardial Infarction(12 months post-procedure)
- Number of Participants Who Experience Clinical Efficacy Composite Endpoint(12 months post-procedure)
- Number of Participants Who Experienced All-Cause Death(12 months post-procedure)
- Number of Participants Who Experienced Minor Bleeding(At 30 days and 12 months post-procedure)
- Number of Participants Who Experience Clinically Significant Prosthetic Valve Thrombosis (VARC-3)(At 6 months and 12 months post-procedure)
- Number of Participants Who Experience Bioprosthetic Valve Deterioration Stage 3 by Echocardiography (VARC-3)(12 months post-procedure)
- Number of Participants Who Experience Hypo-Attenuated Leaflet Thickening (HALT) by CT(12 months post-procedure)
- Number of Participants Who Experienced Non-Procedure-Related Life-Threatening or Disabling Bleeding (VARC-3)(At 30 days and 12 months post-procedure)
- Number of Participants Who Experienced Major Bleeding(At 30 days and 12 months post-procedure)
- Number of Participants Who Experienced Heart Failure Re-Hospitalization(12 months post-procedure)
- Number of Participants Who Experienced Infective Endocarditis(12 months post-procedure)
- Number of Participants Who Experienced Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(At 30 days and 12 months post-procedure)
- Number of Participants Who Experienced NYHA Class Improvement(At 30 days and 12 months post-procedure)
研究者
Wei Lai, MD
Principal Investigator
Shanghai Zhongshan Hospital
研究点 (1)
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