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
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 304
- Locations
- 11
- Primary Endpoint
- A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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>
- •Patients who can not use the study drug orally.
Arms & Interventions
Oral anticoagulation plus dual antiplatelet therapy
Intervention: Acetylsalicylic Acid + clopidogrel + acenocoumarol (Drug)
Dual antiplatelet therapy
Intervention: Acetylsalicylic Acid + clopidogrel (Drug)
Outcomes
Primary Outcomes
A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death
Time Frame: 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 Outcomes
- Incidence of major and minor bleeding(until 12 months)
- Adverse events(until 12 months)