Anticoagulation in Stent Intervention

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Atrial Fibrillation, Stroke

Intervention / Treatment
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* Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol
* Drug: Acetylsalicylic Acid + clopidogrel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral anticoagulation plus dual antiplatelet therapy<br> | Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol<br>* 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<br>|
| Active Comparator: Dual antiplatelet therapy<br> | Drug: Acetylsalicylic Acid + clopidogrel<br>* Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | until 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major and minor bleeding |  | until 12 months | 
| Adverse events |  | until 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, Coronary Stent implantation, Low-moderate risk of stroke, dual antiplatelet therapy, anticoagulation