NCT00882739

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Ospedale San Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Clopidogrel 300 mg	Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
DRUG	Clopidogrel 600 mg	Patients will receive a 600 mg clopidogrel loading dose at first medical contact
DRUG	Clopidogrel 900 mg	Patients will receive a 900 mg clopidogrel loading dose at first medical contact

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-07-01
• First posted: 2009-04-16
• Last updated: 2012-01-26

Locations

1 site across 1 country: Italy