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NCT Number: NCT01642134

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Heart Valve Diseases Nervous System Diseases Stroke Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Policlínica de Guipuzcoa.SA, San Sebastián, Guipúzcoa, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aspirin+clopidogrel (Duoplavin)

Drug

100 mg aspirin ;75 mg clopidogrel 3º months

Other names: DUOPLAVIN (aspirin 100 mg + clopidogrel 75 mg)., SINTROM (ACENOCUMAROL).

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 1 hour before TAVI, 1 hour and 24 hours after TAVI

  2. Identify the development of cognitive impairment after TAVI

    Time frame: 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.

  3. Evaluate the Quality of life after TAVI.

    Time frame: Pre-TAVI, and at 1º; 3º and 6º month after TAVI.

    By the application of Euroquol EQ5.

Sponsors and collaborators

Lead sponsor

Andres Iñiguez Romo, MD, PhD

Other Gov

Registry information

Official study 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

Acronym: AUREA

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2012
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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