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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
  Purpose

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.


Condition Intervention Phase
Aortic Valve Stenosis
Stroke
Drug: aspirin+clopidogrel (Duoplavin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital de Meixoeiro:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 124
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: aspirin+clopidogrel (Duoplavin)
100 mg aspirin ;75 mg clopidogrel 3º months
Other Names:
  • DUOPLAVIN (aspirin 100 mg + clopidogrel 75 mg).
  • SINTROM (ACENOCUMAROL).
Sham Comparator: acenocumarol Drug: aspirin+clopidogrel (Duoplavin)
100 mg aspirin ;75 mg clopidogrel 3º months
Other Names:
  • DUOPLAVIN (aspirin 100 mg + clopidogrel 75 mg).
  • SINTROM (ACENOCUMAROL).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642134

Contacts
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

Locations
Spain
Policlínica de Guipuzcoa.SA Not yet recruiting
Donostia, Guipúzcoa, Spain, 20014
Principal Investigator: Mariano Larman Tellechea, MD         
Hospital clinico universitario de Vigo Recruiting
Vigo, Pontevedra, Spain, 36214
Sub-Investigator: Victor A. Jimenez Diaz, MD,Msc         
Sub-Investigator: Jose antonio Baz Alonso, MD         
Sub-Investigator: Carlos M. Diaz Lopez         
Hospital clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Sub-Investigator: Antonio Fernández Ortiz, MD,PHD         
Principal Investigator: Carlos Macaya Miguel, MD;PHD         
Hospital Virgen de la Arrixaca Active, not recruiting
Murcia, Spain, 36214
Sponsors and Collaborators
Andres Iñiguez Romo, MD, PhD
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Andres Iñiguez Romo, MD, PhD, MD; PHD, Hospital de Meixoeiro
ClinicalTrials.gov Identifier: NCT01642134     History of Changes
Other Study ID Numbers: MEIX-VALV-001, 2011-005784-24
Study First Received: June 19, 2012
Last Updated: April 8, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital de Meixoeiro:
Antiplatelet
Anticoagulation

Additional relevant MeSH terms:
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Aspirin
Clopidogrel
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on November 25, 2014