Clopidogrel Efficacy and Acute Coronary Syndromes

February 9, 2009 updated by: Charles University, Czech Republic

The Comparison of Clopidogrel Efficacy in Patients With Acute Myocardial Infarction and Severe Hemodynamic Instability to Patients With Hemodynamically Uncomplicated Myocardial Infarction

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 10034
        • Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Population of 40 consecutive patients is planned, all of them with acute myocardial infarction with ST-segment elevation.

Description

Inclusion Criteria for unstable group:

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

Inclusion Criteria for stable group:

  • acute myocardial infarction

Exclusion Criteria for any:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Unstable
Patient with acute myocardial infarction plus severe hemodynamical instability. It means, on mechanical ventilation and catecholamine support
Stable
Patients with myocardial infarction hemodynamically completely (Killip I)stable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower efficacy of clopidogrel determined by VASP measurement
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Higher frequency of stent thrombosis in the unstable group
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Pavel Osmancik, MD, PhD, Charles University Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLO-OSM-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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