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Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition
This study has been completed.
Sponsored by: Heart Center Bad Krozingen
Information provided by: Heart Center Bad Krozingen
ClinicalTrials.gov Identifier: NCT00302913
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Drug Resistance
Drug: Adjustment of clopidogrel dose

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Clopidogrel Clopidogrel Bisulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition After Elective Coronary Stenting

Further study details as provided by Heart Center Bad Krozingen:

Primary Outcome Measures:
  • Antiplatelet effect after fourteen and twenty-eight days determined by optical aggregometry after stimulation with ADP

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: December 2005
Estimated Study Completion Date: June 2006
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302913

Locations
Germany
Heart Center Bad Krozingen,
Bad Krozingen, Germany, 79189
Sponsors and Collaborators
Heart Center Bad Krozingen
Investigators
Study Director: Franz-Josef Neumann, MD Heart Center Bad Krozingen, Germany
  More Information

Study ID Numbers: HZ-BK-2005-2
Study First Received: March 14, 2006
Last Updated: June 29, 2006
ClinicalTrials.gov Identifier: NCT00302913  
Health Authority: Germany: Ethics Commission

Keywords provided by Heart Center Bad Krozingen:
Clopidogrel
Coronary Artery Disease
Dose-Response Relationship, Drug
Drug Resistance
PCI

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009