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

Phase 4

Completed

• Conditions: Aortic Valve Stenosis; Stroke
• Interventions: Drug: aspirin+clopidogrel (Duoplavin)

• Registration Number: NCT01642134
• Lead Sponsor: Andres Iñiguez Romo, MD, PhD

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-17
• Study Start: 2013-04
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
2. Patients with symptomatic degenerative severe aortic stenosis rejected for conventional surgical aortic valve replacement due to unacceptably high risk and accepted for TAVI procedure
3. Signed informed consent.
4. Patients who are not participating in any other clinical trial or research study.

Exclusion Criteria

1. Patients under oral anticoagulation treatment
2. Patients who can not undergo MRI study
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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duoplavin	aspirin+clopidogrel (Duoplavin)	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.
acenocumarol	aspirin+clopidogrel (Duoplavin)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Pre-TAVI, and at 1º 3º and 6º month 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.
Evaluate the Quality of life after TAVI.	Pre-TAVI, and at 1º; 3º and 6º month after TAVI.	By the application of Euroquol EQ5.

Trial Locations

Locations (4)

Policlínica de Guipuzcoa.SA; 🇪🇸 San Sebastián, Guipúzcoa, Spain

Hospital clinico Universitario Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Clinico Universitario de Malaga; 🇪🇸 Malaga, Spain

Hospital Universitario Álvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain