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TerminatedNCT00638326DOSERUpdated Mar 23, 2010

Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity

A Phase 3 interventional study of clopidogrel and clopidogrel plus placebo in Stable Angina Pectoris and Ad Hoc Percutaneous Coronary Intervention, sponsored by University of Pecs. Terminated at 1 site in Hungary. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-03-23.

Sponsored by University of Pecs · Phase 3, Interventional, and Treatment

Why this study was terminated
Greater differences between randomized patients than previously anticipated
Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Stable Angina Pectoris
  • Ad Hoc Percutaneous Coronary Intervention

Keywords

  • Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents
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In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

This study's planned enrollment of 500 is above the median of 123 across 336 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • 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

    Drug: clopidogrel

  • Active comparator
    3

    Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel

    Drug: clopidogrel plus placebo

Interventions

  • Drugclopidogrel

    150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year

  • Drugclopidogrel 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

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What researchers measure

Primary outcomes

  1. Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.

    Time frame: 12 months

Secondary outcomes

  1. Academic Research Consortium (ARC) definite / probable stent thrombosis

    Time frame: 12 months

  2. Cardiac death and non-fatal myocardial infarction

    Time frame: 12 months

  3. Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding

    Time frame: 12 months

  4. 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer

    Time frame: 25 +/-2 days

  5. VASP-PRI

    Time frame: 25 +/-2 days

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Study locations

1 site
  • Heart Institute, University of Pécs, Dept. of Interventional Cardiology
    Pécs, 7624, Hungary
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References and documents

Publications

  • 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. PubMed 21902692 ↗
  • 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. PubMed 21806387 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00638326
Lead sponsor
University of Pecs
First posted
Mar 19, 2008
Start date
Mar 2008
Primary completion
Sep 2009
Completion
Mar 2010
Last update
Mar 23, 2010

Study contacts

Ivan G Horvath, MD PhD
principal investigator · Heart Institute, University of Pécs, HUNGARY
Daniel Aradi, MD
study director · Heart Institute, University of Pécs, HUNGARY
Andras Komocsi, MD PhD
study chair · Heart Institute, University of Pécs, HUNGARY

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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