Anticoagulation in Stent Intervention

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01141153

Acronym

MUSICA-2

Enrollment

304

Registered

2010-06-10

Start date

2010-06-30

Completion date

2015-12-31

Last updated

2015-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

atrial fibrillation, Coronary Stent implantation, Low-moderate risk of stroke, dual antiplatelet therapy, anticoagulation

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

Interventions

DRUGAcetylsalicylic 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

DRUGAcetylsalicylic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026