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

NCT01642134 | Completed Phase 4 DMC

• 2 other identifiers: MEIX-VALV-0012011-005784-24
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 4

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.

Conditions

Aortic Valve Stenosis; Stroke

Keywords

Antiplatelet; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Identify the development of cognitive impairment after TAVI

  Pre-TAVI, and at 1º 3º and 6º month after TAVI

• Evaluate the Quality of life after TAVI.

  Pre-TAVI, and at 1º; 3º and 6º month after TAVI.

Study Arms (2)

Duoplavin

ACTIVE COMPARATOR

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)

acenocumarol

SHAM COMPARATOR

Drug: aspirin+clopidogrel (Duoplavin)

Interventions

aspirin+clopidogrel (Duoplavin) DRUG

100 mg aspirin ;75 mg clopidogrel 3º months

Also known as: DUOPLAVIN (aspirin 100 mg + clopidogrel 75 mg)., SINTROM (ACENOCUMAROL).

Duoplavin; acenocumarol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
• Patients with symptomatic degenerative severe aortic stenosis rejected for conventional surgical aortic valve replacement due to unacceptably high risk and accepted for TAVI procedure
• Signed informed consent.
• Patients who are not participating in any other clinical trial or research study.

You may not qualify if:

• Patients under oral anticoagulation treatment
• Patients who can not undergo MRI study
• Recent stroke \< 14 days prior, revascularized coronary artery disease or life expectancy \< 12 months
• Patients with proven allergy to aspirin, clopidogrel or acenocoumarol
• 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

Sponsors & Collaborators

• Andres Iñiguez Romo, MD, PhD: lead

Study Sites (4)

Policlínica de Guipuzcoa.SA

San Sebastián, Guipúzcoa, 20014, Spain

Location

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital clinico Universitario Bellvitge

Barcelona, 36201, Spain

Location

Hospital Clinico Universitario de Malaga

Málaga, 36201, Spain

Location

Related Publications (5)

• 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.

  PMID: 21639811 BACKGROUND

• 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.

  PMID: 20961243 BACKGROUND

• 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.

  PMID: 20177005 BACKGROUND

• 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.

  PMID: 11062293 BACKGROUND

• 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.

  PMID: 18375137 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Aortic Valve Stenosis; Stroke

Interventions

Aspirin; Clopidogrel; Acenocoumarol

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Pablo Juan Salvadores, Pharma,MPH

  Hospital Universitario Álvaro Cunqueiro

  STUDY DIRECTOR

• Jose M. Hernandez, MD

  Hospital Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD; PHD

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: July 17, 2012
• Study Start: April 1, 2013
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

ES (4)