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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00839267

Enrollment

Registered

2009-02-09

Start date

2006-06-30

Completion date

2008-12-31

Last updated

2009-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

platelet, VASP, clopidogrel, cardiogenic shock, myocardial infarction, percutaneous coronary intervention

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lower efficacy of clopidogrel determined by VASP measurement	6 months

Secondary

Measure	Time frame
Higher frequency of stent thrombosis in the unstable group	6 months

Countries

Czechia

Outcome results