search
Back to results

Anticoagulation in Stent Intervention (MUSICA-2)

Primary Purpose

Atrial Fibrillation, Stroke

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Acetylsalicylic Acid + clopidogrel + acenocoumarol
Acetylsalicylic Acid + clopidogrel
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, Coronary Stent implantation, Low-moderate risk of stroke, dual antiplatelet therapy, anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Hospital Universitari de Bellvitge
  • Corporación Sanitaria Parc Taulí
  • Hospital Marqués de Valdecilla
  • Hospital Puerta del Hierro
  • Hospital Sant Pau
  • Hospital Universitario Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital Dr.Josep Trueta
  • Hospital Universitario Gregorio Marañón
  • Hospital San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral anticoagulation plus dual antiplatelet therapy

Dual antiplatelet therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of major and minor bleeding
Adverse events

Full Information

First Posted
June 9, 2010
Last Updated
February 23, 2015
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01141153
Brief Title
Anticoagulation in Stent Intervention
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
atrial fibrillation, Coronary Stent implantation, Low-moderate risk of stroke, dual antiplatelet therapy, anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral anticoagulation plus dual antiplatelet therapy
Arm Type
Experimental
Arm Title
Dual antiplatelet therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid + clopidogrel + acenocoumarol
Intervention Description
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
Intervention Name(s)
Acetylsalicylic Acid + clopidogrel
Intervention Description
Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.
Primary Outcome Measure Information:
Title
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
Description
Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment
Time Frame
until 12 months
Secondary Outcome Measure Information:
Title
Incidence of major and minor bleeding
Time Frame
until 12 months
Title
Adverse events
Time Frame
until 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia Sambola, MD Ph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David García -Dorado, MD Ph
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Corporación Sanitaria Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39011
Country
Spain
Facility Name
Hospital Puerta del Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Dr.Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24093846
Citation
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.
Results Reference
derived

Learn more about this trial

Anticoagulation in Stent Intervention

We'll reach out to this number within 24 hrs