Anticoagulation in Stent Intervention (MUSICA-2)

Vall d'Hebron University Hospital (HUVH)

Status and phase

Unknown

Phase 4

Conditions

Atrial Fibrillation

Stroke

Treatments

Drug: Acetylsalicylic Acid + clopidogrel

Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol

Study type

Interventional

Funder types

Other

Identifiers

NCT01141153

2009-017256-27 (EudraCT Number)

MUSICA-2

Details and patient eligibility

About

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

Enrollment

304 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.