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
  Purpose

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.


Condition
Coronary Artery Disease
Drug Resistance

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Impact of the Degree of Peri-Interventional Platelet Inhibition After Loading With Clopidogrel on Early Clinical Outcome of Elective Coronary Stent Placement

Resource links provided by NLM:


Further study details as provided by Heart Center Bad Krozingen:

Estimated Enrollment: 800
Study Start Date: March 2003
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457236

Locations
Germany
Heart Center Bad Krozingen
Bad Krozingen, Germany, 79189
Sponsors and Collaborators
Heart Center Bad Krozingen
Investigators
Study Director: Franz-Josef Neumann, MD Heart Center Bad Krozingen, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00457236     History of Changes
Other Study ID Numbers: HZ-BK-2003-1
Study First Received: April 4, 2007
Last Updated: April 5, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Heart Center Bad Krozingen:
Clopidogrel
Coronary Artery Disease
Dose-Response Relationship, Drug
Drug Resistance
PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014