Anticoagulation in Stent Intervention (MUSICA-2)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

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

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT01141153 History of Changes
Other Study ID Numbers:	MUSICA-2; 2009-017256-27 ( EudraCT Number )
First Posted:	June 10, 2010
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:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Clopidogrel; Ticlopidine; Aspirin; Acenocoumarol; 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; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors