Anticoagulation in Stent Intervention

NCT ID: NCT01141153

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-12-31

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

Conditions

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oral anticoagulation plus dual antiplatelet therapy

Group Type: EXPERIMENTAL

Acetylsalicylic Acid + clopidogrel + acenocoumarol

Intervention Type: DRUG

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

Dual antiplatelet therapy

Group Type: ACTIVE_COMPARATOR

Acetylsalicylic Acid + clopidogrel

Intervention Type: DRUG

Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily

Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonia Sambola, MD Ph

Role: PRINCIPAL_INVESTIGATOR

David García -Dorado, MD Ph

Role: STUDY_DIRECTOR

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Corporación Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Dr.Josep Trueta

Girona, Girona, Spain

Hospital Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital San Carlos

Madrid, Madrid, Spain

Hospital Puerta del Hierro

Majadahonda, Madrid, Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Countries

Spain

References

Sambola A, Montoro JB, Del Blanco BG, Llavero N, Barrabes JA, Alfonso F, Bueno H, Cequier A, Serra A, Zueco J, Sabate M, Rodriguez-Leor O, Garcia-Dorado D. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial. Am Heart J. 2013 Oct;166(4):669-75. doi: 10.1016/j.ahj.2013.07.028. Epub 2013 Sep 14.

Reference Type: DERIVED

PMID: 24093846 (View on PubMed)

Other Identifiers

2009-017256-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MUSICA-2

Identifier Type: -

Identifier Source: org_study_id