Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction (Load & Go)

• TIMI flow [ Time Frame: pre- and post-PCI ] [ Designated as safety issue: No ]
• Corrected TIMI Frame Count (cTFC) [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
• Major bleedings [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Major adverse cardiac events (MACEs) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ] [ Designated as safety issue: No ]
• TIMI 2-3 grade flow of the infarct-related artery [ Time Frame: pre-PCI ] [ Designated as safety issue: No ]
• no reflow phenomenon [ Time Frame: post-PCI ] [ Designated as safety issue: No ]

• TIMI flow [ Time Frame: pre- and post-PCI ] [ Designated as safety issue: No ]
• Corrected TIMI Frame Count (cTFC) [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
• ST segment resolution [ Time Frame: 90' and 180' after primary PCI ] [ Designated as safety issue: No ]
• Major and minor bleedings [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• Major adverse cardiac events (MACEs) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ] [ Designated as safety issue: No ]

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.

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).

• Drug: Clopidogrel 300 mg
  Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
  Other Name: Plavix-®
• Drug: Clopidogrel 600 mg
  Patients will receive a 600 mg clopidogrel loading dose at first medical contact
  Other Name: Plavix-®
• Drug: Clopidogrel 900 mg
  Patients will receive a 900 mg clopidogrel loading dose at first medical contact
  Other Name: Plavix-®

• no pre-treatment
  No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
  Intervention: Drug: Clopidogrel 300 mg
• Experimental: 600 mg loading dose
  600 mg clopidogrel loading dose at first medical contact
  Intervention: Drug: Clopidogrel 600 mg
• Experimental: 900 mg loading dose
  900 mg clopidogrel loading dose at first medical contact
  Intervention: Drug: Clopidogrel 900 mg

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