Anticoagulation in Stent Intervention

Stroke Clinical Trial

— MUSICA-2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01141153
• Other study ID #: MUSICA-2
• Secondary ID: 2009-017256-27
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 9, 2010
• Last updated: February 23, 2015
• Start date: June 2010
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 304
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Dr.Josep Trueta	Girona
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital San Carlos	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Puerta del Hierro	Majadahonda	Madrid
Spain	Corporación Sanitaria Parc Taulí	Sabadell	Barcelona
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death	Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment	until 12 months	No
Secondary	Incidence of major and minor bleeding		until 12 months	Yes
Secondary	Adverse events		until 12 months	Yes