Anticoagulation in Stent Intervention

Phase 4

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol; Drug: Acetylsalicylic Acid + clopidogrel

• Registration Number: NCT01141153
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral anticoagulation plus dual antiplatelet therapy	Acetylsalicylic Acid + clopidogrel + acenocoumarol	-
Dual antiplatelet therapy	Acetylsalicylic Acid + clopidogrel	-

Primary Outcome Measures

Name	Time	Method
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death	until 12 months	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

Name	Time	Method
Incidence of major and minor bleeding	until 12 months
Adverse events	until 12 months

Trial Locations

Locations (11)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Corporación Sanitaria Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Puerta del Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Dr.Josep Trueta; 🇪🇸 Girona, Spain

Hospital San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain