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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00302913
Other study ID # HZ-BK-2005-2
Secondary ID
Status Completed
Phase N/A
First received March 14, 2006
Last updated June 29, 2006
Start date December 2005
Est. completion date June 2006

Study information

Verified date February 2006
Source Heart Center Bad Krozingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Adjustment of clopidogrel dose


Locations

Country Name City State
Germany Heart Center Bad Krozingen, Bad Krozingen

Sponsors (1)

Lead Sponsor Collaborator
Heart Center Bad Krozingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antiplatelet effect after fourteen and twenty-eight days determined by optical aggregometry after stimulation with ADP
Secondary Antiplatelet effect after fourteen and twenty-eight days determined by flow cytometric evaluation of surface protein expression after stimulation with ADP
Secondary Major cardiac events within thirty days (death, myocardial infarction, target vessel reintervention)
Secondary Bleeding and vascular access site complications within thirty days
Secondary Drug-drug interaction of clopidogrel with concomitant treatment
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