Effect of Clopidogrel Loading and Risk of PCI

Coronary Artery Disease Clinical Trial

— EXCELSIOR  

Official title:

Impact of the Degree of Peri-Interventional Platelet Inhibition After Loading With Clopidogrel on Early Clinical Outcome of Elective Coronary Stent Placement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00457236
• Other study ID #: HZ-BK-2003-1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 4, 2007
• Last updated: April 5, 2007
• Start date: March 2003
• Est. completion date: December 2007

Study information

• Verified date: April 2007
• Source: Heart Center Bad Krozingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2007
• 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 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

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

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

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, 

References & Publications (1)

Hochholzer W, Trenk D, Bestehorn HP, Fischer B, Valina CM, Ferenc M, Gick M, Caputo A, Büttner HJ, Neumann FJ. Impact of the degree of peri-interventional platelet inhibition after loading with clopidogrel on early clinical outcome of elective coronary st — View Citation