Anticoagulation in Stent Intervention (MUSICA-2)

February 23, 2015 updated by: Hospital Universitari Vall d'Hebron Research Institute

Test of Efficacy and Safety of the Dual Antiplatelet Therapy Compared to the Combination of Oral Anticoagulant Therapy + Dual Antiplatelet Therapy in Patients With Atrial Fibrillation With Low-moderate Risk Submitted to Coronary Stent Implantation

Objective:

The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg / day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2) who are undergoing PCI-S.

Design:

Randomized, parallel, with two arms, blind evaluation by third parties.

Patients:

304 patients undergoing PCI-S with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2), which requires prevention of thrombosis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

304

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08025
        • Hospital Sant Pau
      • Girona, Spain, 17007
        • Hospital Dr.Josep Trueta
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28040
        • Hospital San Carlos
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trías i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Sabadell, Barcelona, Spain, 08208
        • Corporación Sanitaria Parc Taulí
    • Cantabria
      • Santander, Cantabria, Spain, 39011
        • Hospital Marqués de Valdecilla
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta del Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes older than 18 years.
  • Patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. Patients with acute coronary syndrome or stable angina who are undergoing PCI-S.
  • Patients who have previously given their informed consent to participation in the study.

Exclusion Criteria:

  • Patients who can not be followed by the research team during the 12 months provided for monitoring.
  • Patients with renal failure or serum creatinine above 2 mg • dL-1, neurological deficits, active ulcer or epigastric pain.
  • Patients who continue regular treatment with NSAIDs or other analgesics or corticosteroids.
  • Patients undergoing reoperation.
  • Patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol.
  • Pregnant women.
  • Use of investigational agents or not registered within 30 days of entry into the study.
  • Patients with a history of allergy to study drugs or excipients.
  • Patients with severe valve disease.
  • Patients with CHADS> 2.
  • Patients who can not use the study drug orally.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral anticoagulation plus dual antiplatelet therapy
Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol

Acetylsalicylic Acid 100 mg daily + Clopidogrel 75 mg daily + Acenocoumarol dosage with INR monitoring

Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent
Active Comparator: Dual antiplatelet therapy
Drug: Acetylsalicylic Acid + clopidogrel

Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily

Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
Time Frame: until 12 months
Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment
until 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of major and minor bleeding
Time Frame: until 12 months
until 12 months
Adverse events
Time Frame: until 12 months
until 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Antonia Sambola, MD Ph
  • Study Director: David García -Dorado, MD Ph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 23, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSICA-2
  • 2009-017256-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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