2024-515361-34-00招募中4 期
Head-to-head compaRison of single versus dual antiplatelet treatMent strategY after percutaneous left atrial appenDage closure: A MULticenter, randomizEd sTudy. The ARMYDA-AMULET study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 606
- 试验地点
- 18
- 主要终点
- Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3 (7).
研究概览
简要总结
To demonstrate that the strategy with single antiplatelet therapy (SAPT) is not inferior to the current standard antiplatelet therapy (DAPT) after LAA closure regarding the cumulative incidence of the net composite endpoint, including death, thrombotic complications and bleeding events, at 6 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women aged =18 years signing a specific informed consent
- •Patients with a planned percutaneous LAA closure
- •Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score =2
- •Patients suitable for treatment with aspirin and clopidogrel according to the Summaries of product characteristics (SmPCs)
- •Patients considered unsuitable for long-term oral anticoagulant therapy due to a high bleeding risk. Patients will be judged unsuitable for anticoagulation because of bleeding-prone comorbidities, history of previous bleeding (with or without anticoagulant treatment) or an expected low adherence to therapy
- •Patient’s availability to undergo the follow-up visits scheduled for the study
- •Negative pregnancy testing (if applicable), performed at the time of enrollment
排除标准
- •CHADS-VAsc score 0-1
- •Myocardial infarction or percutaneous coronary intervention <6 months
- •Major surgery within one month
- •Intracranial neoplasm, aneurysm or arterio-venous malformation
- •Platelet count <50,000/µL
- •Recent stroke (<1 month)
- •Fibrinolytic therapy within 10 days
- •Baseline hemoglobin <9 g/dL
- •Pregnant woman
- •Breast-feeding
- •Donne fertili impossibilitate ad utilizzare contraccettivi durante lo studio
- •Requirement for on-going therapy with clopidogrel at the time of screening evaluation (e.g. current therapy with clopidogrel at the time of the screening evaluation will be an exclusion criterion)
- •Known hypersensitivity to the study drugs (aspirin or clopidogrel)
- •Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event
- •Planned oral anticoagulant therapy after the procedure
- •Moderate to severe mitral stenosis
- •Mechanical heart prosthetic valve
- •Active endocarditis
- •Active bleeding
结局指标
主要结局
Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3 (7).
Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3 (7).
次要结局
- DRT at 3 and 6 months by TEE
- Any-cause death
- Incidence of ischemic stroke or SEE at 3 and 6 months
- Incidence of any bleeding at 3 and 6 months
- Incidence of BARC classification bleeding ≥3 at 3 and 6 months
研究者
Stefania Biagini
Scientific
Fondazione Toscana Gabriele Monasterio
研究点 (18)
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