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Clopidogrel Efficacy and Acute Coronary Syndromes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839267
First Posted: February 9, 2009
Last Update Posted: February 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charles University, Czech Republic
  Purpose
The purpose of this study is to compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction.

Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Comparison of Clopidogrel Efficacy in Patients With Acute Myocardial Infarction and Severe Hemodynamic Instability to Patients With Hemodynamically Uncomplicated Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Lower efficacy of clopidogrel determined by VASP measurement [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Higher frequency of stent thrombosis in the unstable group [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Whole blood

Enrollment: 40
Study Start Date: June 2006
Study Completion Date: December 2008
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Population of 40 consecutive patients is planned, all of them with acute myocardial infarction with ST-segment elevation.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839267


Locations
Czech Republic
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czech Republic, 10034
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Pavel Osmancik, MD, PhD Charles University Prague
  More Information

Responsible Party: Pavel Osmancik, Charles University Prague
ClinicalTrials.gov Identifier: NCT00839267     History of Changes
Other Study ID Numbers: CLO-OSM-02
First Submitted: February 6, 2009
First Posted: February 9, 2009
Last Update Posted: February 10, 2009
Last Verified: February 2009

Keywords provided by Charles University, Czech Republic:
platelet
VASP
clopidogrel
cardiogenic shock
myocardial infarction
percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs