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

Stroke Clinical Trial

— AUREA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642134
• Other study ID #: MEIX-VALV-001
• Secondary ID: 2011-005784-24
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Hospital de Meixoeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Embolism
• Intracranial Embolism
• Stroke

Intervention

Drug:
• aspirin+clopidogrel (Duoplavin)
100 mg aspirin ;75 mg clopidogrel 3º months

Locations

Country	Name	City	State
Spain	Hospital clinico Universitario Bellvitge	Barcelona
Spain	Hospital Clinico Universitario de Malaga	Malaga
Spain	Policlínica de Guipuzcoa.SA	San Sebastián	Guipúzcoa
Spain	Hospital Universitario Álvaro Cunqueiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Andres Iñiguez Romo, MD, PhD

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. doi: 10.1016/j.ejcts.2008.02.024. Epub 2008 Mar 28. Review. Erratum in: Eur J Cardiothorac Surg. 2008 Oct;34(4):934. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months
Secondary	Determine the incidence of new areas of cerebral infarction by MRI between the different routes of vascular access and the various valve devices.		1 hour before TAVI, 1 hour and 24 hours after TAVI
Secondary	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.	Pre-TAVI, and at 1º 3º and 6º month after TAVI
Secondary	Evaluate the Quality of life after TAVI.	By the application of Euroquol EQ5.	Pre-TAVI, and at 1º; 3º and 6º month after TAVI.

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