Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, stroke
Treatments acetylsalicylic acid + clopidogrel + acenocoumarol, acetylsalicylic acid + clopidogrel
Phase phase 4
Sponsor Hospital Universitari Vall d'Hebron Research Institute
Start date June 2010
End date December 2015
Trial size 304 participants
Trial identifier NCT01141153, 2009-017256-27, MUSICA-2

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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)
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.

Primary Outcomes

Measure
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
time frame: until 12 months

Secondary Outcomes

Measure
Incidence of major and minor bleeding
time frame: until 12 months
Adverse events
time frame: until 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Antonia Sambola, MD Ph
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute.