Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After TAVI

Study Overview
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Brief Summary
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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.

Detailed Description
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Transcatheter aortic valve implantation (TAVI) procedure using any of their vascular access is an option with proven benefit definitively for treatment of severe symptomatic aortic stenosis in patients considered unsuitable for conventional open heart surgery. By avoiding the hemodynamic effects, cardiovascular and cerebral microembolic load of cardiopulmonary bypass circulation, it is assumed that the TAVI procedure is beneficial despite the risk of neurological complications. Currently antithrombotic therapy after the procedure is not standardized. International treatment guidelines recommends that post-operative patients with a conventional surgical aortic bioprosthesis maintain oral anticoagulation for 3 months after the procedure, unless otherwise noted for its continuation. Whereas some studies have postulated that in patients with aortic bioprostheses, dual antiplatelet therapy is as effective to prevent major cardiac and cerebrovascular events as oral anticoagulation, with a lower incidence of bleeding complications at 3 months of treatment, the investigators formulated the following hypothesis: • There is a lower incidence of major cardiac and cerebrovascular events in patients with dual antiplatelet therapy compared to patients with oral anticoagulation for 3 months after implantation of an aortic bioprosthesis TAVI procedure.

Official Title
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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

Conditions
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Aortic Valve Stenosis, Stroke

Intervention / Treatment
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* Drug: aspirin+clopidogrel (Duoplavin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial. Patients with symptomatic degenerative severe aortic stenosis rejected for conventional surgical aortic valve replacement due to unacceptably high risk and accepted for TAVI procedure Signed informed consent. Patients who are not participating in any other clinical trial or research study. Exclusion Criteria: Patients under oral anticoagulation treatment Patients who can not undergo MRI study Recent stroke < 14 days prior, revascularized coronary artery disease or life expectancy < 12 months Patients with proven allergy to aspirin, clopidogrel or acenocoumarol Patients that after TAVI procedure can not undergo a regimen of dual antiplatelet therapy or oral anticoagulation for 3 months due to any new post-TAVI medical indication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duoplavin<br>Both active substances in DuoPlavin: clopidogrel and acetylsalicylic acid, are inhibitors of platelet aggregation. Clopidogrel stops the platelets aggregating by blocking ADP. Acetylsalicylic acid the platelets aggregating by blocking the prostaglandin cyclo oxygenase. | Drug: aspirin+clopidogrel (Duoplavin)<br>* 100 mg aspirin ;75 mg clopidogrel 3º months<br>* Other names: SINTROM (ACENOCUMAROL).;|
| Sham Comparator: acenocumarol<br> | Drug: aspirin+clopidogrel (Duoplavin)<br>* 100 mg aspirin ;75 mg clopidogrel 3º months<br>* Other names: SINTROM (ACENOCUMAROL).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incidence of new areas of cerebral infarction by MRI between the different routes of vascular access and the various valve devices. |  | 1 hour before TAVI, 1 hour and 24 hours after TAVI | 
| Identify the development of cognitive impairment after TAVI | By the application of: 1)Mini-Mental State Examination (MMSE); 2)SF 36 (spanish version); 3)The NIHSS (National Institute of Health Stroke Scale). The evaluation of the neurological tests will be performed by a certificated neurologist. | Pre-TAVI, and at 1º 3º and 6º month after TAVI | 
| Evaluate the Quality of life after TAVI. | By the application of Euroquol EQ5. | Pre-TAVI, and at 1º; 3º and 6º month after TAVI. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiplatelet, Anticoagulation