Clopidogrel Efficacy and Acute Coronary Syndromes

NCT ID: NCT00839267

Last Updated: 2009-02-10

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

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction.

Detailed Description

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Clopidogrel exists in oral form only. As a prodrug, it has to be metabolized to the active form by cytochrome system in the liver. Both facts could lead to lower efficacy of the drug in hemodynamically unstable patients, where splanchnic and liver hypoperfusion is present. We hypothesised that clopidogrel efficacy is insufficient in patients with acute myocardial infarction and severe hemodynamic instability. Therefore we would like to compare the effect of clopidogrel in unstable STEMI patients on mechanical ventilation with stable STEMI patients.

Conditions

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Acute Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Unstable

Patient with acute myocardial infarction plus severe hemodynamical instability. It means, on mechanical ventilation and catecholamine support

No interventions assigned to this group

Stable

Patients with myocardial infarction hemodynamically completely (Killip I)stable.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* acute STEMI
* mechanical ventilation
* the need for catecholamine support.


* acute myocardial infarction

Exclusion Criteria

* previous treatment with clopidogrel
* clopidogrel administration during transport by ambulance
* known intolerance to clopidogrel
* history of thrombocytopenia (\<150,000 platelets/ml)
* pre-existing liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Charles University Prague

Principal Investigators

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Pavel Osmancik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charles University Prague

Locations

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Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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CLO-OSM-02

Identifier Type: -

Identifier Source: org_study_id

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