Clopidogrel Efficacy and Acute Coronary Syndromes

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839267
• Other study ID #: CLO-OSM-02
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: February 9, 2009
• Start date: June 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Czech Republic	Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower efficacy of clopidogrel determined by VASP measurement		6 months	No
Secondary	Higher frequency of stent thrombosis in the unstable group		6 months	No