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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Hospital de Meixoeiro
Sponsor:
Information provided by (Responsible Party):
Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro
ClinicalTrials.gov Identifier:
NCT01642134
First received: June 19, 2012
Last updated: April 8, 2013
Last verified: April 2013

June 19, 2012
April 8, 2013
April 2013
April 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01642134 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Identify the development of cognitive impairment after TAVI [ Time Frame: Pre-TAVI, and at 1º 3º and 6º month after TAVI ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Pre-TAVI, and at 1º; 3º and 6º month after TAVI. ] [ Designated as safety issue: No ]
    By the application of Euroquol EQ5.
Same as current
Not Provided
Not Provided
 
Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After TAVI
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Aortic Valve Stenosis
  • Stroke
Drug: aspirin+clopidogrel (Duoplavin)
100 mg aspirin ;75 mg clopidogrel 3º months
Other Names:
  • DUOPLAVIN (aspirin 100 mg + clopidogrel 75 mg).
  • SINTROM (ACENOCUMAROL).
  • Active Comparator: 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.
    Intervention: Drug: aspirin+clopidogrel (Duoplavin)
  • Sham Comparator: acenocumarol
    Intervention: Drug: aspirin+clopidogrel (Duoplavin)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
March 2015
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Andres Iñiguez Romo, PHD,MD +0034986.811163 andres.iniguez.romo@sergas.es
Contact: Carlos M. Diaz Lopez 0034986211758 ext 211758 carlos.maria.diaz.lopez@sergas.es
Spain
 
NCT01642134
MEIX-VALV-001, 2011-005784-24
Yes
Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro
Andres Iñiguez Romo, MD, PhD
Not Provided
Study Chair: Andres Iniguez Romo, MD;PHD Hospital clinico universitario Vigo
Study Director: Victor Jimenez Diaz, MD;Msc Hospital clinico universitario Vigo
Principal Investigator: Carlos Macaya Miguel, MD;PHD Hospital San Carlos, Madrid
Principal Investigator: Mariano Valdes Chavarri, MD;PHD Hospital Virgen de la Arrixaca, Murcia
Principal Investigator: Mariano Larman Tellechea, MD Policlínica de Guipuzcoa SA San Sebastián
Study Director: Carlos M Diaz Lopez, MSC Hospital Meixoeiro
Hospital de Meixoeiro
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP