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OpenTrials
Completed

NCT Number: NCT00839267

Clopidogrel Efficacy and Acute Coronary Syndromes

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Prague, 10034, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lower efficacy of clopidogrel determined by VASP measurement

    Time frame: 6 months

Secondary outcomes

  1. Higher frequency of stent thrombosis in the unstable group

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2008
First posted
Feb 9, 2009
Registry last updated
Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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