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

San Donato Group (GSD)

Status and phase: Completed; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Drug: Clopidogrel 900 mg; Drug: Clopidogrel 600 mg; Drug: Clopidogrel 300 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00882739

Arezzo002

EUDRACT 2009-010295-23

Details and patient eligibility

About

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.

Full 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).

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 3 patient groups

no pre-treatment

Other group

Description:

No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting

Treatment:

Drug: Clopidogrel 300 mg

600 mg loading dose

Experimental group

Description:

600 mg clopidogrel loading dose at first medical contact

Treatment:

Drug: Clopidogrel 600 mg

900 mg loading dose

Experimental group

Description:

900 mg clopidogrel loading dose at first medical contact

Treatment:

Drug: Clopidogrel 900 mg