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Anticoagulation in Stent Intervention (MUSICA-2)

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ClinicalTrials.gov Identifier: NCT01141153
Recruitment Status : Unknown
Verified February 2015 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : June 10, 2010
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Tracking Information
First Submitted Date  ICMJE June 9, 2010
First Posted Date  ICMJE June 10, 2010
Last Update Posted Date February 24, 2015
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2010)
  • Incidence of major and minor bleeding [ Time Frame: until 12 months ]
  • Adverse events [ Time Frame: until 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulation in Stent Intervention
Official Title  ICMJE 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
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Stroke
Intervention  ICMJE
  • 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

  • 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.

Study Arms  ICMJE
  • Experimental: Oral anticoagulation plus dual antiplatelet therapy
    Intervention: Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol
  • Active Comparator: Dual antiplatelet therapy
    Intervention: Drug: Acetylsalicylic Acid + clopidogrel
Publications * Sambola A, Montoro JB, Del Blanco BG, Llavero N, Barrabés JA, Alfonso F, Bueno H, Cequier A, Serra A, Zueco J, Sabaté M, Rodríguez-Leor O, García-Dorado D. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial. Am Heart J. 2013 Oct;166(4):669-75. doi: 10.1016/j.ahj.2013.07.028. Epub 2013 Sep 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 9, 2010)
304
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01141153
Other Study ID Numbers  ICMJE MUSICA-2
2009-017256-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Universitari Vall d'Hebron Research Institute
Study Sponsor  ICMJE Hospital Universitari Vall d'Hebron Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonia Sambola, MD Ph
Study Director: David García -Dorado, MD Ph
PRS Account Hospital Universitari Vall d'Hebron Research Institute
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP