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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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no pre-treatment

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

Group Type OTHER

Clopidogrel 300 mg

Intervention Type DRUG

Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting

600 mg loading dose

600 mg clopidogrel loading dose at first medical contact

Group Type EXPERIMENTAL

Clopidogrel 600 mg

Intervention Type DRUG

Patients will receive a 600 mg clopidogrel loading dose at first medical contact

900 mg loading dose

900 mg clopidogrel loading dose at first medical contact

Group Type EXPERIMENTAL

Clopidogrel 900 mg

Intervention Type DRUG

Patients will receive a 900 mg clopidogrel loading dose at first medical contact

Interventions

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Clopidogrel 300 mg

Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting

Intervention Type DRUG

Clopidogrel 600 mg

Patients will receive a 600 mg clopidogrel loading dose at first medical contact

Intervention Type DRUG

Clopidogrel 900 mg

Patients will receive a 900 mg clopidogrel loading dose at first medical contact

Intervention Type DRUG

Other Intervention Names

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Plavix-® Plavix-® Plavix-®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No