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Anticoagulation in Stent Intervention (MUSICA-2)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute Identifier:
First received: June 9, 2010
Last updated: February 23, 2015
Last verified: February 2015


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.


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


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

Condition Intervention Phase
Atrial Fibrillation
Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol
Drug: Acetylsalicylic Acid + clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death [ Time Frame: until 12 months ] [ Designated as safety issue: No ]
    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:
  • Incidence of major and minor bleeding [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 304
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01141153

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute Identifier: NCT01141153     History of Changes
Other Study ID Numbers: MUSICA-2  2009-017256-27 
Study First Received: June 9, 2010
Last Updated: February 23, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
atrial fibrillation
Coronary Stent implantation
Low-moderate risk of stroke
dual antiplatelet therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
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
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on December 06, 2016