Clinical trial NCT00638326: Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity
Official title: 150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stable Angina Pectoris
Ad Hoc Percutaneous Coronary Intervention
Keywords: Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 500
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.


Eligibility 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

Primary outcomes:
measure: Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.
timeFrame: 12 months
Secondary outcomes:
measure: Academic Research Consortium (ARC) definite / probable stent thrombosis
timeFrame: 12 months
measure: Cardiac death and non-fatal myocardial infarction
timeFrame: 12 months
measure: Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding
timeFrame: 12 months
measure: 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer
timeFrame: 25 +/-2 days
measure: VASP-PRI
timeFrame: 25 +/-2 days
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Heart Institute, University of Pécs, Dept. of Interventional Cardiology
Study officials:
affiliation: Heart Institute, University of Pécs, HUNGARY
name: Ivan G Horvath, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute, University of Pécs, HUNGARY
name: Daniel Aradi, MD
role: STUDY_DIRECTOR
affiliation: Heart Institute, University of Pécs, HUNGARY
name: Andras Komocsi, MD PhD
role: STUDY_CHAIR
References:
citation: Aradi D, Rideg O, Vorobcsuk A, Magyarlaki T, Magyari B, Konyi A, Pinter T, Horvath IG, Komocsi A. Justification of 150 mg clopidogrel in patients with high on-clopidogrel platelet reactivity. Eur J Clin Invest. 2012 Apr;42(4):384-92. doi: 10.1111/j.1365-2362.2011.02594.x. Epub 2011 Sep 9.
citation: Rideg O, Komocsi A, Magyarlaki T, Tokes-Fuzesi M, Miseta A, Kovacs GL, Aradi D. Impact of genetic variants on post-clopidogrel platelet reactivity in patients after elective percutaneous coronary intervention. Pharmacogenomics. 2011 Sep;12(9):1269-80. doi: 10.2217/pgs.11.73. Epub 2011 Aug 1.