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 - A MULticenter, randomizEd sTudy the ARMYDA-AMULET study

FONDAZIONE TOSCANA GABRIELE MONASTERIO0 个研究点目标入组 574 人开始时间: 2021年6月8日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•-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 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 115
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 459

•-CHADS-VAsc score 0-1
•-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
•-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
•-Women unavailable to use contraception during the study period

发起方