Status:
COMPLETED
Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition
Lead Sponsor:
University Heart Center Freiburg - Bad Krozingen
Conditions:
Coronary Artery Disease
Drug Resistance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, single-center evaluation of the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation.
Detailed Description
Background: The EXCELSIOR trial demonstrated a 7-fold increased risk for death, myocardial infarction and target vessel reintervention within 30 days in patients with platelet inhibition below median ...
Eligibility Criteria
Inclusion
- Patients undergoing elective coronary stenting
- Pretreatment with a bolus dose of 600mg of clopidogrel at least 2 hours prior to coronary stent implantation
- Pretreatment with aspirin ≥ 100 mg per day for at least 7 days
- Age \> 18 years
- Written consent
Exclusion
- Troponin T on admission \> 0.03 ng/mL
- Myocardial infarction or fibrinolytic therapy within the previous 14 days
- Cardiogenic shock
- Contraindication for aspirin or clopidogrel
- Oral anticoagulation
- Pretreatment with heparin or a thienopyridine within the previous 14 days
- Use of a GP IIb/IIIa-receptor antagonist during PCI
- Platelet count \< 100.000/µl
- Severe disorders of the coagulation system
- Severe impairment of liver or kidney function
- Cancer
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00302913
Start Date
December 1 2005
End Date
June 1 2006
Last Update
July 4 2006
Active Locations (1)
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1
Heart Center Bad Krozingen,
Bad Krozingen, Germany, 79189