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 (MUSICA-2)

NCT01141153 Phase 4 UNKNOWN

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

Details

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	Phase 4
Status	UNKNOWN
Enrolment	304
Start date	2010-06
Completion	2015-12

Conditions

• Atrial Fibrillation
• Stroke

Interventions

• Acetylsalicylic Acid + clopidogrel + acenocoumarol
• Acetylsalicylic Acid + clopidogrel

Primary outcomes

• A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death — 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

Countries

Spain