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

Phase 4

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Clopidogrel 600 mg; Drug: Clopidogrel 900 mg; Drug: Clopidogrel 300 mg

• Registration Number: NCT00882739
• Lead Sponsor: Ospedale San Donato

Brief 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).

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2011-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-25
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
TIMI Myocardial Perfusion Grade (TMPG)	post-PCI

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy