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Anticoagulation in Stent Intervention (MUSICA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol Drug: Acetylsalicylic Acid + clopidogrel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of major and minor bleeding [ Time Frame: until 12 months ]
  2. Adverse events [ Time Frame: until 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141153


Locations
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Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39011
Hospital Puerta del Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Sant Pau
Barcelona, Spain, 08025
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Dr.Josep Trueta
Girona, Spain, 17007
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Antonia Sambola, MD Ph
Study Director: David García -Dorado, MD Ph
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01141153    
Other Study ID Numbers: MUSICA-2
2009-017256-27 ( EudraCT Number )
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
atrial fibrillation
Coronary Stent implantation
Low-moderate risk of stroke
dual antiplatelet therapy
anticoagulation
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Aspirin
Acenocoumarol
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants