Clinical trial NCT01141153: Anticoagulation in Stent Intervention
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Stroke
Keywords: atrial fibrillation
Coronary Stent implantation
Low-moderate risk of stroke
dual antiplatelet therapy
anticoagulation
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
timeFrame: until 12 months
Secondary outcomes:
measure: Incidence of major and minor bleeding
timeFrame: until 12 months
measure: Adverse events
timeFrame: until 12 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Corporación Sanitaria Parc Taulí
state: Barcelona
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Puerta del Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Girona
country: Spain
facility: Hospital Dr.Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital San Carlos
Study officials:
name: Antonia Sambola, MD Ph
role: PRINCIPAL_INVESTIGATOR
name: David García -Dorado, MD Ph
role: STUDY_DIRECTOR
References:
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.