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

NCT ID: NCT01642134

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-06-30

Brief 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.

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.

Conditions

Aortic Valve Stenosis; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

aspirin+clopidogrel (Duoplavin)

Intervention Type: DRUG

100 mg aspirin ;75 mg clopidogrel 3º months

acenocumarol

Group Type: SHAM_COMPARATOR

aspirin+clopidogrel (Duoplavin)

Intervention Type: DRUG

100 mg aspirin ;75 mg clopidogrel 3º months

Interventions

aspirin+clopidogrel (Duoplavin)

100 mg aspirin ;75 mg clopidogrel 3º months

Intervention Type: DRUG

Other Intervention Names

DUOPLAVIN (aspirin 100 mg + clopidogrel 75 mg).; SINTROM (ACENOCUMAROL).

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andres Iñiguez Romo, MD, PhD

OTHER_GOV

Sponsor Role: lead

Responsible Party

Andres Iñiguez Romo, MD, PhD

MD; PHD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andres Iniguez Romo, MD;PHD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Alvaro Cunqueiro

Victor A. Jimenez Diaz, MD;Msc

Role: PRINCIPAL_INVESTIGATOR

Hospital clinico universitario Vigo

Mariano Larman Tellechea, MD

Role: PRINCIPAL_INVESTIGATOR

Policlínica de Guipuzcoa SA San Sebastián

Pablo Juan Salvadores, Pharma,MPH

Role: STUDY_DIRECTOR

Hospital Universitario Álvaro Cunqueiro

Jose M. Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Victoria

Locations

Policlínica de Guipuzcoa.SA

San Sebastián, Guipúzcoa, Spain

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital clinico Universitario Bellvitge

Barcelona, , Spain

Hospital Clinico Universitario de Malaga

Málaga, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 21639811 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20961243 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20177005 (View on PubMed)

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. doi: 10.1161/01.str.31.11.2670.

Reference Type: BACKGROUND

PMID: 11062293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18375137 (View on PubMed)

Related Links

http://www.cardiologia-vigo.com/

Related Info

Other Identifiers

2011-005784-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MEIX-VALV-001

Identifier Type: -

Identifier Source: org_study_id