Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition

This study has been completed.
Sponsor:
Information provided by:
Heart Center Bad Krozingen
ClinicalTrials.gov Identifier:
NCT00302913
First received: March 14, 2006
Last updated: June 29, 2006
Last verified: February 2006

March 14, 2006
June 29, 2006
December 2005
Not Provided
Antiplatelet effect after fourteen and twenty-eight days determined by optical aggregometry after stimulation with ADP
Antiplatelet effect after 14 and 28 days determined by optical aggregometry after stimulation with ADP
Complete list of historical versions of study NCT00302913 on ClinicalTrials.gov Archive Site
  • Antiplatelet effect after fourteen and twenty-eight days determined by flow cytometric evaluation of surface protein expression after stimulation with ADP
  • Major cardiac events within thirty days (death, myocardial infarction, target vessel reintervention)
  • Bleeding and vascular access site complications within thirty days
  • Drug-drug interaction of clopidogrel with concomitant treatment
  • - Antiplatelet effect after 14 and 28 days determined by flow cytometric evaluation of surface protein expression after stimulation with ADP
  • - Major cardiac events within 30 days (death, myocardial infarction, target vessel reintervention)
  • - Bleeding and vascular access site complications within 30 days
  • - Drug-drug interaction of clopidogrel with concomitant treatment
Not Provided
Not Provided
 
Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition
Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition After Elective Coronary Stenting

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.

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 of study cohort after a bolus dose of 600 mg of clopidogrel. The median of platelet inhibition in this cohort was 14 % optical aggregation after stimulation with 5 µM ADP.

Aim: To evaluate the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation

Methods: This prospective, single-center study will evaluate antiplatelet effects in 120 patients receiving a bolus dose of 600 mg of clopidogrel before undergoing elective coronary stent implantation. Platelet inhibition will be evaluated 24 hours, 14 and 28 days after coronary intervention using optical aggregometry (5 µM ADP) and determination of surface protein expression by flow cytometry (P-Selectin, gp55, activated GP IIb/IIIa). If 24 hours after coronary stent implantation optical aggregation is >14 %, patients will receive an additional bolus dose of 300 mg of clopidogrel, followed by a daily dose of 150 mg for at least 28 days. If optical aggregation at this point of time is ≤14 % patients will receive a daily dose of 75 mg of clopidogrel. No further dose adjustments during follow up will be performed.

Hypothesis: Adjustment of clopidogrel dose in patients with insufficient platelet inhibition determined by optical aggregometry will provide a comparable antiplatelet effect as in patients with sufficient platelet inhibition after coronary stent implantation.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Drug Resistance
Drug: Adjustment of clopidogrel dose
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2006
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00302913
HZ-BK-2005-2
Not Provided
Not Provided
Heart Center Bad Krozingen
Not Provided
Study Director: Franz-Josef Neumann, MD Heart Center Bad Krozingen, Germany
Heart Center Bad Krozingen
February 2006

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