Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- Composite outcome of the following events: death from any cause, myocardial infarction, stroke all causes, valve thrombosis and hemorrhage ≥ 2 as defined by the VARC 3 (Valve Academic Research Consortium scale).
研究概览
简要总结
The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC 3 (other complications; Kappetein et al 2012)..
详细描述
The secondary objectives of this study are to evaluate the following at 3 months, 6 months and 12 months after TAVI in both groups:
- Mortality (all causes).
- Cardiovascular mortality.
- The occurrence of myocardial infarction.
- The occurrence of stroke.
- The occurrence of valve thrombosis.
- The occurrence of major bleeding (BARC ≥ 3).
- The occurrence of minor bleeding (2 ≤ BARC <3).
- Treatment compliance.
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
- •The patient or his/her representative must have given free and informed consent and signed the consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow-up
- •The patient underwent a successful transcutaneous implant procedure for an aortic valve
- •The patient required anticoagulant treatment (AVK or DOAC) excepted rivaroxaban the day of inclusion
- •The patient is stable on anticoagulant treatment
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient or his/her representative refuses to sign the consent
- •It is impossible to correctly inform the patient or his/her representative
- •The patient is pregnant or breastfeeding
- •The patient has a contraindication (or an incompatible drug association) for a treatment used in this study
- •The patient had a coronary stent for less than 12 months
- •The patient does not require treatment with aspirin or any other antiplatelet agent
- •The patient has a history of aspirin allergy
- •High bleeding risk; such as platelets <50,000 / mm3 during screening, Hb <8.5 g / dL, history of intracranial hemorrhage or subdural hematoma, major surgery, parenchymal organ biopsy or severe trauma within 30 days before inclusion, active gastrointestinal ulcer in the last 3 months;
- •History of Stroke in the last 3 months;
- •Moderate or severe liver affection associated with coagulopathy
- •Active infectious endocarditis
- •Active tumor treated at the time of inclusion associated with expected survival less than one year
- •Not following countraindications specific to the molecules used fo the patients receiving DOAC
研究组 & 干预措施
vitamin K antagonist or Direct oral anticoagulant treatment
In this group, patients will receive monotherapy via anticoagulant (AVK or DOAC) excepted rivaroxaban; this treatment given corresponds to the anticoagulant treatment the patient was receiving before surgery. A data collection book for monitoring INR values and dates for the next 12 months is given to the patient.
Intervention: anticoagulant
干预措施: Vitamin K antagonist or direct oral anticoagulant treatment (Drug)
vitamin K antagonist or Direct oral anticoagulant + Aspirin
In this group, patients will receive combination therapy via anticoagulant (AVK or DOAC) and aspirin, whose daily dose is between 75 mg and 100 mg; the anticoagulant treatment administered corresponds to the anticoagulant treatment the patient was receiving before the procedure, monitored and adapted according to current recommendations. A data collection book for monitoring INR values and dates for the next 12 months is given to the patient.
Intervention: anticoagulant Intervention: Aspirin
干预措施: Vitamin K antagonist or direct oral anticoagulant treatment (Drug)
vitamin K antagonist or Direct oral anticoagulant + Aspirin
In this group, patients will receive combination therapy via anticoagulant (AVK or DOAC) and aspirin, whose daily dose is between 75 mg and 100 mg; the anticoagulant treatment administered corresponds to the anticoagulant treatment the patient was receiving before the procedure, monitored and adapted according to current recommendations. A data collection book for monitoring INR values and dates for the next 12 months is given to the patient.
Intervention: anticoagulant Intervention: Aspirin
干预措施: Aspirin (Drug)
结局指标
主要结局
Composite outcome of the following events: death from any cause, myocardial infarction, stroke all causes, valve thrombosis and hemorrhage ≥ 2 as defined by the VARC 3 (Valve Academic Research Consortium scale).
时间窗: Month 12
次要结局
- Minor hemorrhage (2 ≤ BARC < 3)(Month 12)
- All cause death according to the VARC 3 criteria(month 12)
- Death due to cardio-vascular causes according to the VARC 2 criteria(month 1)
- Death due to cardio-vascular causes according to the VARC 3 criteria(month 12)
- Valve thrombosis according to the VARC 3 criteria(Month 12)
- Major hemorrhage (BARC ≥ 3)(Month 12)
- Myocardial infarction according to VARC 3 criteria(month 12)
- Myocardial infarction according to VARC 2 criteria(month 6)
- Stroke (all cause) according to the VARC 3 criteria(month 12)
- Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)(Month 12)