Official Title: “Doubling the Maintenance Dose of Clopidogrel After Percutaneous Coronary Intervention in Low Responders to Therapy”

The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the 9-month incidence of thromboischemic events compared to 75 mg clopidogrel after elective percutaneous coronary intervention.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: clopidogrel
  • 150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
• Drug: clopidogrel plus placebo
  • 75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel
• Experimental: 2
  • Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days
• Active Comparator: 3
  • Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel

Primary Measures

• Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation.
  • Time Frame: 9 months
    Safety Issue?: No

Secondary Measures

• Academic Research Consortium (ARC-1) definite stent thrombosis
  • Time Frame: 9 months
    Safety Issue?: No
• Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation
  • Time Frame: 30 days
    Safety Issue?: No
• Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation or TIMI major/minor bleeding
  • Time Frame: 9 months
    Safety Issue?: Yes
• 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer
  • Time Frame: 25 +/-2 days
    Safety Issue?: No
• VASP-PRI
  • Time Frame: 25 +/-2 days
    Safety Issue?: No

Inclusion Criteria:

• Clopidogrel-naïve stable angina pectoris (CCS I-III)
• Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation

Exclusion Criteria:

• Acute coronary syndrome (STEMI, NSTEMI or unstable angina)
• Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks
• Contraindication to antiplatelet therapy
• Significant LM stenosis
• PCI due to instent restenosis
• Lesion located in bypass grafts
• Stroke in past one year
• Reduced life expectancy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pecs

Overall Clinical Trial Officials and Contacts

Ivan G Horvath, MD PhD Principal Investigator Heart Institute, University of Pécs, HUNGARY  

Overall Contact: Daniel Aradi, MD 0036302355639 daniel.aradi@kk.pte.hu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638326

Study ID Number: Pecs-001

ClinicalTrials.gov Identifier: NCT00638326

Health Authority: Hungary: National Institute of Pharmacy