jRCTs031220614进行中（未招募）不适用
Non-antithrombotic therapy after transcatheter aortic valve implantation trial (NAPT trial)
未提供0 个研究点目标入组 400 人开始时间: 2023年4月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 主要终点
- Composite endpoint
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who underwent transfemoral TAVI for aortic stenosis
- •Patients aged 20 years or older at the time of informed consent
- •Patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study
排除标准
- •Those with perioperative complications at the time of TAVI (conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular dissection, cerebral infarction/cerebral hemorrhage, new atrial fibrillation, new atrioventricular block)
- •Individuals requiring antiplatelet agents for reasons other than TAVI (historty of myocardial infraction, history of PCI, history of EVT, hisotry of cerebral infraction and transient ischaemic stroke, with significant coronary artery narrowing, with high-grade carotid artery narrowing, and others judged as requiring antiplatelet therapy by the chief researcher or a sub-investigator)
- •Patients requiring oral anticoagulants (patients with atrial fibrillation, history of pulmonary embolism or deep venous thrombosis, and other patients who are deemed to require anticoagulation therapy by the investigator or subinvestigator)
- •Patients with eGFR <30 and patients on hemodialysis/peritoneal dialysis.
- •Patients with a history of valve replacement in the heart valves.
- •Patients who are pregnant, have childbearing potential, wish to become pregnant, or are breastfeeding.
- •Patients who have a concomitant medical illness associated with expected survival less than one year.
- •Patients who have the contraindications for aspirin.
- •Patients with a diagnosis of severe allergy to aspirin or a history of hypersensitivity.
- •Patients requiring a legally acceptable representative, patients unable to obtain written informed consent, or patients unable to understand the outline or purpose of the study.
- •Other patients for whom the principal investigator or the subinvestigator judges the participation in the study inappropriate.
结局指标
主要结局
Composite endpoint
时间窗: From randomization to end of study (minimum 1 year, maximum 3 years of follow-up)
Composite endpoint consisting of: - All-cause deaths - Myocardial infarction - Stroke from any cause - Bleeding
次要结局
- Bleeding Events(Randomization to Study End)
- Overall Mortality(Randomization to Study End)
- Cardiovascular Death(Randomization to Study End)
- Acute Myocardial Infarction(Randomization to Study End)
- Systemic Embolism(Randomization to end of study)
- Heart Failure Readmissions(Randomization to study completion)
- Stroke(Randomization to end of study)
- Transient Ischemic Attack(Randomization to Study End)
- Overall Readmissions(Randomization to Study End)
- Aortic Valve Mean Pressure Gradient and Effective Orifice Area(6 Months and 1 Year)
研究者
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