Effect of Clopidogrel Loading and Risk of PCI (EXCELSIOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Heart Center Bad Krozingen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Heart Center Bad Krozingen
ClinicalTrials.gov Identifier:
NCT00457236
First received: April 4, 2007
Last updated: April 5, 2007
Last verified: April 2007

April 4, 2007
April 5, 2007
March 2003
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Complete list of historical versions of study NCT00457236 on ClinicalTrials.gov Archive Site
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Effect of Clopidogrel Loading and Risk of PCI
Impact of the Degree of Peri-Interventional Platelet Inhibition After Loading With Clopidogrel on Early Clinical Outcome of Elective Coronary Stent Placement

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.

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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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  • Coronary Artery Disease
  • Drug Resistance
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
December 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00457236
HZ-BK-2003-1
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Heart Center Bad Krozingen
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Study Director: Franz-Josef Neumann, MD Heart Center Bad Krozingen, Germany
Heart Center Bad Krozingen
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP