NCT00638326

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 23, 2010

Status Verified

March 1, 2010

Enrollment Period

1.5 years

First QC Date

March 11, 2008

Last Update Submit

March 20, 2010

Conditions

Stable Angina PectorisAd Hoc Percutaneous Coronary Intervention

Keywords

Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (5)

  • Academic Research Consortium (ARC) definite / probable stent thrombosis

    12 months

  • Cardiac death and non-fatal myocardial infarction

    12 months

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

    12 months

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

    25 +/-2 days

  • VASP-PRI

    25 +/-2 days

Study Arms (3)

1

NO INTERVENTION

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

2

EXPERIMENTAL

Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days

Drug: clopidogrel

3

ACTIVE COMPARATOR

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

Drug: clopidogrel plus placebo

Interventions

clopidogrelDRUG

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

2
clopidogrel plus placeboDRUG

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

3

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute, University of Pécs, Dept. of Interventional Cardiology

Pécs, 7624, Hungary

Location

Related Publications (2)

  • 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.

    PMID: 21902692DERIVED

  • 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.

    PMID: 21806387DERIVED

MeSH Terms

Conditions

Angina, StableThrombosis

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ivan G Horvath, MD PhD

    Heart Institute, University of Pécs, HUNGARY

    PRINCIPAL INVESTIGATOR

  • Daniel Aradi, MD

    Heart Institute, University of Pécs, HUNGARY

    STUDY DIRECTOR

  • Andras Komocsi, MD PhD

    Heart Institute, University of Pécs, HUNGARY

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 19, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2009

Study Completion

March 1, 2010

Last Updated

March 23, 2010

Record last verified: 2010-03

Locations

HU(1)