Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.

Study Overview
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Brief Summary
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REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. Such treatment strategy will not cause increased risk of bleeding complications. In many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term therapy results, lower risk of ischemic complications. Currently, data regarding to the results of the above treatment are still limited.

Detailed Description
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The objectives of the study is: to evaluate the effect of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment to evaluate the safety of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) in patients with myocardial infarction undergoing interventional treatment

Official Title
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Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •≥18 years of age, Myocardial Infarction with or without ST segment elevation, clopidogrel treatment (confirmed administration of loading dose of 600 mg or chronic therapy of 75 mg/day), signed written informed consent. Exclusion Criteria: prior administration of fibrinolytic therapy and/or GP IIb/IIIa inhibitors within the last 14 days, prior administration of prasugrel within the last 14 days, subject with known hypersensitivity to the active ingredient or other components of the product increased risk of bleeding complications:bleeding diathesis, thrombocytopenia (platelet count < 100 000/mm3), oral anticoagulant therapy (INR >1.6), uncontrolled hypertension (systolic blood pressure >200 mmHg), major bleeding, trauma or surgery within the last 30 days, acute renal failure, acute liver failure, pregnancy.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel - Repeated Loading Dose<br>repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day) | Drug: Clopidogrel<br>* repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)<br>|
| Active Comparator: Clopidogrel - standard of care<br>no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day) | Drug: Clopidogrel<br>* no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inhibition of platelet aggregation | inhibition of platelet aggregation at the 30-day follow-up visit. | at 30 days follow-up | 
| inhibition of platelet aggregation | inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo | at 1st hour after administration of the repeated loading dose of clopidogrel / placebo | 
| inhibition of platelet aggregation | inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo | at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo | 
| inhibition of platelet aggregation | inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo | at 6th hour after administration of the repeated loading dose of clopidogrel / placebo | 
| inhibition of platelet aggregation | inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo | at 24th hour after administration of the repeated loading dose of clopidogrel / placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome | frequency of bleeding complications within 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, NSTEMI, clopidogrel, Areplex, REL-0609