Anticoagulation in Stent Intervention "MUSICA-2"

Active, not recruiting

Phase 4 Results N/A

Trial Description

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

Conditions

Interventions

  • Acetylsalicylic Acid (aspirin) + clopidogrel + acenocoumarol Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Oral anticoagulation plus dual antiplatelet therapy
  • Acetylsalicylic Acid (aspirin) + clopidogrel Drug
    Intervention Desc: Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.
    ARM 1: Kind: Experimental
    Label: Dual antiplatelet therapy
  • Acetylsalicylic Acid + clopidogrel + acenocoumarol Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Oral anticoagulation plus dual antiplatelet therapy
  • Acetylsalicylic Acid + clopidogrel Drug
    Intervention Desc: Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.
    ARM 1: Kind: Experimental
    Label: Dual antiplatelet therapy

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death until 12 months No
Secondary Incidence of major and minor bleeding until 12 months Yes
Secondary Adverse events until 12 months Yes

Sponsors