Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).

Official Title
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Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy.

Conditions
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Acute Coronary Disease, Angina Unstable

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: acetylsalicyclic acid (ASA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated Exclusion Criteria: Use of anticoagulants within 10 days with an international normalized ratio (INR) > 1.5 or planned use during the hospitalisation period Administration of clopidogrel > 75 mg prior to randomization Contraindication to clopidogrel or aspirin Active bleeding or significant risk of bleeding

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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel high dose treatment regimen + ASA high dose<br> | Drug: Clopidogrel<br>* oral administration<br>* Other names: Plavix;Drug: acetylsalicyclic acid (ASA)<br>* oral administration<br>|
| Experimental: Clopidogrel high dose treatment regimen + ASA low dose<br> | Drug: Clopidogrel<br>* oral administration<br>* Other names: Plavix;Drug: acetylsalicyclic acid (ASA)<br>* oral administration<br>|
| Active Comparator: Clopidogrel standard treatment regimen + ASA high dose<br> | Drug: Clopidogrel<br>* oral administration<br>* Other names: Plavix;Drug: acetylsalicyclic acid (ASA)<br>* oral administration<br>|
| Active Comparator: Clopidogrel standard treatment regimen + ASA low dose<br> | Drug: Clopidogrel<br>* oral administration<br>* Other names: Plavix;Drug: acetylsalicyclic acid (ASA)<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison | The primary endpoint is the first occurrence of any of the following events: Cardiovascular death (any death with a clear cardiovascular or unknown cause), Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC). | 30 days | 
| First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison |  | 30 days | 
| First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level |  | 30 days | 
| First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison | Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC. | 30 days | 
| Occurrence of Major Bleeding - ASA Dose Level Comparison |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet aggregation inhibitors, acute coronary disease, percutaneous coronary