Anticoagulation in Stent Intervention
MUSICA-2
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
2 other identifiers
interventional
304
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 atrial-fibrillation
Started Jun 2010
Longer than P75 for phase_4 atrial-fibrillation
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 24, 2015
February 1, 2015
5.5 years
June 9, 2010
February 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
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 Outcomes (2)
Incidence of major and minor bleeding
until 12 months
Adverse events
until 12 months
Study Arms (2)
Oral anticoagulation plus dual antiplatelet therapy
EXPERIMENTALDual antiplatelet therapy
ACTIVE COMPARATORInterventions
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
Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, 39011, Spain
Hospital Dr.Josep Trueta
Girona, Girona, 17007, Spain
Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital San Carlos
Madrid, Madrid, 28040, Spain
Hospital Puerta del Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Related Publications (1)
Sambola A, Montoro JB, Del Blanco BG, Llavero N, Barrabes JA, Alfonso F, Bueno H, Cequier A, Serra A, Zueco J, Sabate M, Rodriguez-Leor O, Garcia-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.
PMID: 24093846DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonia Sambola, MD Ph
- STUDY DIRECTOR
David García -Dorado, MD Ph
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2010
First Posted
June 10, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 24, 2015
Record last verified: 2015-02