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

Last updated: January 25, 2012
Sponsor: Ospedale San Donato
Overall Status: Completed

Phase

4

Condition

Blood Clots

Congestive Heart Failure

Angina

Treatment

N/A

Clinical Study ID

NCT00882739
Arezzo002
EUDRACT 2009-010295-23
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 newLeft Bundle Branch Block

  • With indication to primary PCI, presenting within 12 hour from symptoms onset

  • Age > 18 years

  • Planned PCI

  • Informed Consent

Exclusion

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

Total Participants: 168
Study Start date:
April 01, 2009
Estimated Completion Date:

Study 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).

Connect with a study center

  • Cardiovascular Department, Ospedale S.Donato

    Arezzo, AR 52100
    Italy

    Site Not Available

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