Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition

Coronary Artery Disease Clinical Trial

Official title:

Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition After Elective Coronary Stenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302913
• Other study ID #: HZ-BK-2005-2
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Drug Resistance
• Myocardial Ischemia

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