Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.

Detailed Description
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This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system. The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3).

Official Title
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Safety and Efficacy of Three Different Loading Doses of Clopidogrel, Administered at First Medical Contact in Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty. The LOAD & GO Trial

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Clopidogrel 300 mg
* Drug: Clopidogrel 600 mg
* Drug: Clopidogrel 900 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST-elevation myocardial infarction: chest pain lasting more than 30 minutes not responsive to nitrates ST-segment elevation of more than 0.1 mV in two or more leads on the ECG, or new Left Bundle Branch Block With indication to primary PCI, presenting within 12 hour from symptoms onset Age > 18 years Planned PCI Informed Consent Exclusion Criteria: bleeding diathesis allergy to study drugs pregnancy the performance of a rescue PCI after thrombolysis known existence of a disease resulting in a life expectancy of <6 months lack of informed consent

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: no pre-treatment<br>No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting | Drug: Clopidogrel 300 mg<br>* Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting<br>* Other names: Plavix-®;|
| Experimental: 600 mg loading dose<br>600 mg clopidogrel loading dose at first medical contact | Drug: Clopidogrel 600 mg<br>* Patients will receive a 600 mg clopidogrel loading dose at first medical contact<br>* Other names: Plavix-®;|
| Experimental: 900 mg loading dose<br>900 mg clopidogrel loading dose at first medical contact | Drug: Clopidogrel 900 mg<br>* Patients will receive a 900 mg clopidogrel loading dose at first medical contact<br>* Other names: Plavix-®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI Myocardial Perfusion Grade (TMPG) |  | post-PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI flow |  | pre- and post-PCI | 
| Corrected TIMI Frame Count (cTFC) |  | post-PCI | 
| Major bleedings |  | 30 days | 
| Major adverse cardiac events (MACEs) |  | 30 days | 
| Platelet Reactive Units (PRU) as assessed by VerifyNow™ System |  | pre-PCI | 
| TIMI 2-3 grade flow of the infarct-related artery |  | pre-PCI | 
| no reflow phenomenon |  | post-PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angiography, percutaneous coronary intervention, Platelet Aggregation Inhibitors, Platelet Function Tests