Doubling the Maintenance Dose of Clopidogrel After Percutaneous Coronary Intervention in Low Responders to Therapy
Information source: University of Pecs
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stable Angina Pectoris; Percutaneous Coronary Intervention
Intervention: clopidogrel (Drug); clopidogrel plus placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Pecs Official(s) and/or principal investigator(s):
Ivan G Horvath, MD PhD, Principal Investigator, Affiliation: Heart Institute, University of Pécs, HUNGARY
Daniel Aradi, MD, Study Director, Affiliation: Heart Institute, University of Pécs, HUNGARY
Andras Komocsi, MD PhD, Study Chair, Affiliation: Heart Institute, University of Pécs, HUNGARY
Overall contact:
Daniel Aradi, MD, Phone: 0036302355639, Email: daniel.aradi@kk.pte.hu
Summary
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.
Clinical Details
Official title: Doubling the Maintenance Dose of Clopidogrel After Percutaneous Coronary Intervention in Low Responders to Therapy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation.
Secondary outcome: Academic Research Consortium (ARC-1) definite stent thrombosisCardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation or TIMI major/minor bleeding 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer VASP-PRI
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Daniel Aradi, MD, Phone: 0036302355639, Email: daniel.aradi@kk.pte.hu
Heart Institute, University of Pécs, Dept. of Interventional Cardiology, Pécs 7624, Hungary; Recruiting
Ivan Horvath, MD PhD, Phone: 00363322339, Email: ivan.g.horvath@aok.pte.hu
Balazs Magyari, MD, Sub-Investigator
Erik Kovacs, MD, Sub-Investigator
Attila Konyi, MD, Sub-Investigator
Tunde Pinter, MD, Sub-Investigator
Additional Information
Starting date: March 2008
Ending date: September 2010
Last updated: February 12, 2009
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