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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 June 2017 by Andres Iñiguez Romo, MD, PhD, 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: June 2, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: 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 Andres Iñiguez Romo, MD, PhD, 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 ]

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 ]
  • 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.

  • 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.


Estimated Enrollment: 124
Study Start Date: April 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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: Pablo Juan Salvadores, Pharma, MPH 0034986825564 ext 514564 pablo.juan.salvadores@sergas.es
Contact: Victor A. Jimenez Díaz, MD, MPH 0034986825564 ext 514564 victor.alfonso.jimenez.diaz@sergas.es

Locations
Spain
Policlínica de Guipuzcoa.SA Recruiting
San Sebastián, Guipúzcoa, Spain, 20014
Principal Investigator: Mariano Larman Tellechea, MD         
Hospital Universitario Álvaro Cunqueiro Recruiting
Vigo, Pontevedra, Spain, 36312
Principal Investigator: Victor A. Jimenez Diaz, MD,MPH         
Sub-Investigator: Jose A. Baz Alonso, MD         
Sub-Investigator: Pablo Juan Salvadores, PHARMA, MPH         
Principal Investigator: Andres Iñiguez Romo, MD, pHD         
Hospital clinico Universitario Bellvitge Recruiting
Barcelona, Spain, 36201
Contact: Angel Ramon Cequier Fillat, MD         
Principal Investigator: Angel Ramon Cequier Fillat, MD         
Hospital Clinico Universitario de Malaga Recruiting
Malaga, Spain, 36201
Contact: Jose maria hernandez, md         
Principal Investigator: Jose maria Hernandez, MD         
Sponsors and Collaborators
Andres Iñiguez Romo, MD, PhD
Investigators
Principal Investigator: Andres Iniguez Romo, MD;PHD Hospital Universitario Alvaro Cunqueiro
Principal Investigator: Victor A. Jimenez Diaz, MD;Msc Hospital clinico universitario Vigo
Principal Investigator: Mariano Larman Tellechea, MD Policlínica de Guipuzcoa SA San Sebastián
Study Director: Pablo Juan Salvadores, Pharma,MPH Hospital Universitario Álvaro Cunqueiro
Principal Investigator: Jose M. Hernandez, MD Hospital Virgen de la Victoria
  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 ( EudraCT Number )
Study First Received: June 19, 2012
Last Updated: June 2, 2017

Keywords provided by Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro:
Antiplatelet
Anticoagulation

Additional relevant MeSH terms:
Embolism
Aortic Valve Stenosis
Intracranial Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thromboembolism
Aspirin
Ticlopidine
Clopidogrel
Acenocoumarol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017