Anticoagulation in Stent Intervention - Full Text View

Sponsor:	Hospital Universitari Vall d'Hebron Research Institute
Information provided by (Responsible Party):	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT01141153

Purpose

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

Condition	Intervention	Phase
Atrial Fibrillation Stroke	Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol Drug: Acetylsalicylic Acid + clopidogrel	Phase 4

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Aspirin Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:

A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death [ Time Frame: until 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	304
Study Start Date:	June 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Oral anticoagulation plus dual antiplatelet therapy	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
Active Comparator: Dual antiplatelet therapy	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141153

Contacts

Contact: Antonia Sambola, MD Ph	34932746000 ext 3714	asambola@yahoo.com
Contact: Nadia Llavero, MD	34934894031	nadiallavero@gmail.com

Locations

Spain
Hospital Germans Trias i Pujol	Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Oriol Rodríguez, MD Ph
Principal Investigator: Oriol Rodríguez, MD Ph
Hospital Universitari de Bellvitge	Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Ángel Cequier, MD Ph
Principal Investigator: Ángel Cequier, MD Ph
Hospital Marqués de Valdecilla	Recruiting
Santander, Cantabria, Spain, 39011
Contact: Javier Zueco, MD Ph
Principal Investigator: Javier Zueco, MD Ph
Hospital Puerta del Hierro	Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Javier Goicolea, MD Ph
Principal Investigator: Javier Goicolea, MD Ph
Hospital Clínic de Barcelona	Recruiting
Barcelona, Spain, 08036
Contact: Manuel Sabaté, MD Ph
Principal Investigator: Manuel Sabater, MD Ph
Hospital Sant Pau	Recruiting
Barcelona, Spain, 08025
Contact: Antoni Serra, MD Ph
Principal Investigator: Antoni Serra, MD Ph
Hospital Universitario Vall d'Hebron	Recruiting
Barcelona, Spain, 08035
Contact: Antonia Sambola, MD Ph 34932746000 ext 3714 asambola@yahoo.es
Contact: Nadia Llavero 34934894031 nadiallavero@gmail.com
Sub-Investigator: Eduard Bosch, MD
Hospital Dr.Josep Trueta	Recruiting
Girona, Spain, 17007
Contact: Martí Puigfel, MD Ph
Principal Investigator: Martí Puigfel, MD Ph
Hospital San Carlos	Recruiting
Madrid, Spain, 28040
Contact: Fernando Alfonso, MD Ph
Principal Investigator: Fernando Alfonso, MD Ph
Hospital Universitario Gregorio Marañón	Recruiting
Madrid, Spain, 28007
Contact: Héctor Bueno, MD Ph
Principal Investigator: Héctor Bueno, MD Ph

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

Principal Investigator:	Antonia Sambola, MD Ph
Study Director:	David García -Dorado, MD Ph

More Information

No publications provided

Responsible Party:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT01141153 History of Changes
Other Study ID Numbers:	MUSICA-2, 2009-017256-27
Study First Received:	June 9, 2010
Last Updated:	January 4, 2012
Health Authority:	Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:

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

Additional relevant MeSH terms:

Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Acenocoumarol
Aspirin
Clopidogrel
Anticoagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2012