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

Brief Title

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

Official Title

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

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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 Determine the incidence of new areas of cerebral infarction by MRI between the different routes of vascular access and the various valve devices.

Condition

Aortic Valve Stenosis

Intervention

aspirin+clopidogrel (Duoplavin)

Study Arms / Comparison Groups

 Duoplavin

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 2013

Completion Date

June 30, 2019

Primary Completion Date

June 30, 2019

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andres Iniguez Romo, MD;PHD, ,

Location Countries

Spain

Location Countries

Spain

Administrative Informations

NCT ID

NCT01642134

Organization ID

MEIX-VALV-001

Secondary IDs

2011-005784-24

Responsible Party

Sponsor-Investigator

Study Sponsor

Andres Iñiguez Romo, MD, PhD

Study Sponsor

Andres Iniguez Romo, MD;PHD, Principal Investigator, Hospital Universitario Alvaro Cunqueiro

Verification Date

August 2019