PHASE IV Study of Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After Percutaneous Aortic Valve Implantation. Multicenter Randomized Clinical Trial (AUREA)

NCT01642134 Phase 4 COMPLETED

The purpose of this study is to determine the incidence of major vascular events (ischemic or haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral anticoagulation or dual antiplatelet therapy) in both arms followed TAVI.

Details

Lead sponsor	Andres Iñiguez Romo, MD, PhD
Phase	Phase 4
Status	COMPLETED
Enrolment	124
Start date	2013-04
Completion	2019-06-30

Conditions

• Aortic Valve Stenosis
• Stroke

Interventions

• aspirin+clopidogrel (Duoplavin)

Primary outcomes

• Evaluate the effectiveness of dual antiplatelet therapy versus oral anticoagulation for prevention of cerebral thromboembolism by the detection of new areas of cerebral infarction by Magnetic Resonance Imaging (MRI) 3 months after TAVI. — 3 months

Countries

Spain