Effect of Clopidogrel Loading and Risk of PCI

• Conditions: Coronary Artery Disease; Drug Resistance

• Registration Number: NCT00457236
• Lead Sponsor: University Heart Center Freiburg - Bad Krozingen

Brief Summary

This study is a prospective, single-center evaluation of the impact of the variability in platelet response after loading with clopidogrel on the peri-interventional risk of patients undergoing PCI.

Detailed Description

Background: Platelet responses after loading with clopidogrel are highly variable. The impact of this variability on the peri-interventional risk of patients undergoing PCI has not been investigated prospectively.

Objectives: Our prospective study test the hypothesis that the 30-day clinical outcome of elective percutaneous catheter intervention (PCI) differs between strata defined by quartiles of platelet aggregation after loading with 600mg of clopidogrel. Further on we will investigate impact of the variability in platelet response on long-term outcome after PCI.

Methods: Our study will include consecutive patients undergoing elective coronary stent placement. Before PCI, patients receive a loading dose of 600mg of clopidogrel followed by 75mg daily. Primary end point is the 30-day composite of death, myocardial infarction and target lesion revascularization (MACE). Platelet aggregation was assessed immediately before PCI by optical aggregometry (5µmol/L ADP).

Sample size calculation was based on ISAR-REACT which comprised a cohort with similar selection criteria and treatment strategy. Thus, we assume an incidence of the primary end point of 4.2%. We design our study to test the hypothesis that the incidence of the primary end point differed by quartiles of ADP-induced platelet aggregation. We intend to have a power of 0.80 to detect an effect size of 0.015 (for example 3-fold risk in 4th quartile) with a 2-sided P-value less than 0.05. With these assumptions we obtain a sample size of at least 748 and aime for a cohort of 800.

Study Timeline

• Study Start: 2003-03
• Status Verified: 2007-04
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-05
• Last Update Submitted: 2007-04-05
• Study First Posted: 2007-04-06
• Last Update Posted: 2007-04-06
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Patients undergoing elective coronary stenting
• Pretreatment with a bolus dose of 600mg of clopidogrel 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Heart Center Bad Krozingen; 🇩🇪 Bad Krozingen, Germany