ALBION Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis

Study Overview
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Brief Summary
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To compare the Kinetics of inhibition of platelet aggregation (aggregometry) and platelet activation (flow cytometry) with different loading doses of clopidogrel To evaluate the effect on various parameters of inflammation and necrosis and the safety of these loading doses

Official Title
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Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis.

Conditions
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Ischemia

Intervention / Treatment
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* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient hospitalised with ischemic symptoms (onset < 48 hours) and at least one of the following characteristics of NSTEMI: ECG ST or T changes positive troponin Patient treated on admission with 250-500 mg aspirin (oral or IV) and who will receive low dose aspirin (< or = 100 mg daily) from the next day on Patient treated with bid LMWH (indicated dosage for this indication) Exclusion Criteria: Catheterization scheduled within 24 hours after randomisation Patient presenting an absolute contra-indication to the use of clopidogrel and/or ASA: - history of drug allergy to thienopyridine derivatives or ASA Severe uncontrolled hypertension (BP > 180 / 100 despite therapy) Platelet count < 100 000 / mm3 Neutrophil count < 1800 / mm3 Patient with increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy History of severe systemic bleeding Patient with any contraindication to LMWH Patient treated with clopidogrel within the last 10 days Patient treated with oral anticoagulants or hirudin or planned to receive these products during the hospitalisation period Patient treated with ticlopidine, dipyridamol, NSAIDs (including Cox1 and Cox2 inhibitors), cilostazol, GPIIb IIIa antagonists or planned to receive any of these products within the next 24 hours following randomisation. Patient whose arm venous status is incompatible with an indwelling catheter Patient presenting an evolving cancer Patient with NYHA class IV heart failure Intubated and ventilated patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clopidogrel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum intensity of platelet aggregation induced by ADP 5 µmol/L. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetic profile by aggregometry. Kinetic profile of platelet activation by flow cytometry - Inflammation parameters/markers of necrosis. Death, myocardial infarction, ischemic recurrences leading to revascularisation and/or rehospitalisation.Safety. |  |  |