Dual antiplatelet therapy versus oral anticoagulation for a short time to prevent cerebral embolism after percutaneous aortic valve implantation. Multicenter randomized clinical trial.

Andres Iñiguez Romo0 个研究点目标入组 120 人开始时间: 2012年3月29日最近更新: 2012年6月26日

试验速览

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•1 .- Adult patients (? 18 years) with ability to understand and accept the participation in the clinical trial.
•2 .- Patients with symptomatic degenerative severe aortic stenosis confirmed by imaging studies or invasive method, evaluated by the team of Cardiothoracic Surgery and rejected conventional surgical aortic valve replacement due to unacceptably high risk and accepted for TAVI procedure;
•3 .- That they have signed informed consent.
•4 .- Patients who are not participating in any clinical trial or research study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•1 .- Patients who previously regime are under oral anticoagulation or antiplatelet therapy and post-procedure TAVI have to maintain dual antiplatelet therapy or anticoagulation
•2 .- Patients who can not undergo an MRI study for various reasons; 3 .- recent stroke <14 days prior, revascularized coronary artery disease or life expectancy <12 months;
•4 .- Patients with proven allergy to aspirin, clopidogrel or acenocoumarol;
•5 .- Patients after TAVI procedure can not undergo a regimen of dual antiplatelet therapy or oral anticoagulation for 3 months for any new post-TAVI medical indication;
•6 .- Patients who are pregnant or breastfeeding.

发起方

Andres Iñiguez Romo