Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clopidogrel Efficacy and Acute Coronary Syndromes

This study has been completed.
Information provided by:
Charles University, Czech Republic Identifier:
First received: February 6, 2009
Last updated: February 9, 2009
Last verified: February 2009

February 6, 2009
February 9, 2009
June 2006
Not Provided
Lower efficacy of clopidogrel determined by VASP measurement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Lower efficacy of clopidogrel determined by VASP measurement [ Time Frame: After study completition ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00839267 on Archive Site
Higher frequency of stent thrombosis in the unstable group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Higher frequency of stent thrombosis in the unstable group [ Time Frame: After study completition ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Clopidogrel Efficacy and Acute Coronary Syndromes
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.

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.

Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA

Whole blood

Probability Sample

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

Acute Myocardial Infarction
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2008
Not Provided

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
18 Years to 90 Years
Contact information is only displayed when the study is recruiting subjects
Czech Republic
Pavel Osmancik, Charles University Prague
Charles University, Czech Republic
Not Provided
Principal Investigator: Pavel Osmancik, MD, PhD Charles University Prague
Charles University, Czech Republic
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP