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Trial #NCT01642134
Aortic Valve Stenosis Clinical Trials

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
Study ID: MEIX-VALV-001; Secondary ID: 2011-005784-24; Source: Hospital de Meixoeiro
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country Spain
Study type Interventional
Enrollment 124
Start date April 2013
Completion date March 2015
Phase Phase 4
Sponsor Hospital de Meixoeiro
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.
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:
Gender: Both
Age: 18 Years - N/A
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
Outcome:
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.
    Time frame: 3 months
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.
    Time frame: 1 hour before TAVI, 1 hour and 24 hours after TAVI
  • Evaluate the Quality of life after TAVI.
    By the application of Euroquol EQ5.
    Time frame: Pre-TAVI, and at 1º; 3º and 6º month after TAVI.
  • Identify the development of cognitive impairment 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.
    Time frame: Pre-TAVI, and at 1º 3º and 6º month after TAVI
Contacts:
  • Andres Iniguez Romo, MD;PHD; Hospital clinico universitario Vigo (Study Chair)
  • Carlos M Diaz Lopez, MSC; Hospital Meixoeiro (Study Director)
  • Carlos Macaya Miguel, MD;PHD; Hospital San Carlos, Madrid (Principal Investigator)
  • Mariano Larman Tellechea, MD; Policlínica de Guipuzcoa SA San Sebastián (Principal Investigator)
  • Mariano Valdes Chavarri, MD;PHD; Hospital Virgen de la Arrixaca, Murcia (Principal Investigator)
  • Victor Jimenez Diaz, MD;Msc; Hospital clinico universitario Vigo (Study Director)
  • Andres Iñiguez Romo, PHD,MD;
    Phone: +0034986.811163
  • Carlos M. Diaz Lopez;
    Phone: 0034986211758
Location Country Status
Policlínica de Guipuzcoa.SA Donostia, Guipúzcoa Spain Not yet recruiting
Hospital clinico universitario de Vigo Vigo, Pontevedra Spain Recruiting
Hospital clinico San Carlos Madrid, Spain Not yet recruiting
Hospital Virgen de la Arrixaca Murcia, Spain Active, not recruiting
Sponsors:
  • Andres Iñiguez Romo, MD, PhD - (Lead Sponsor)

Related trials: References:
  • Dunning J, Versteegh M, Fabbri A, Pavie A, Kolh P, Lockowandt U, Nashef SA; EACTS Audit and Guidelines Committee. Guideline on antiplatelet and anticoagulation management in cardiac surgery. Eur J Cardiothorac Surg. 2008 Jul;34(1):73-92. Epub 2008 Mar 28. Review. Erratum in: Eur J Cardiothorac Surg. 2008 Oct;34(4):934.
  • Herrmann M, Vos P, Wunderlich MT, de Bruijn CH, Lamers KJ. Release of glial tissue-specific proteins after acute stroke: A comparative analysis of serum concentrations of protein S-100B and glial fibrillary acidic protein. Stroke. 2000 Nov;31(11):2670-7.
  • Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, Johansson U, Wendt D, Jakob HG, Forsting M, Sack S, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010 Feb 23;121(7):870-8. doi: 10.1161/CIRCULATIONAHA.109.855866.
  • Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607.
  • Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
Terms
  • Anticoagulation
  • Antiplatelet
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