NCT00858715

Brief Summary

Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for adverse events after coronary stenting. In the present study, platelet reactivity will be determined by 6 different platelet function tests in patients on dual antiplatelet therapy after angioplasty and stenting for peripheral, coronary and carotid artery disease. One hundred patients showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for 3 months. The aim of the present study is to investigate the effects of intensified antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased clopidogrel-mediated platelet inhibition after percutaneous intervention with stent implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

4 years

First QC Date

March 9, 2009

Last Update Submit

December 11, 2012

Conditions

AtherosclerosisAngioplasty

Keywords

ClopidogrelAspirinAntithrombotic therapyPlatelet function testing

Outcome Measures

Primary Outcomes (2)

  • Occurence of major adverse cardiovascular events (MACE)

    3 months

  • Occurence of major adverse cardiovascular events (MACE)

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

75 mg clopidogrel + 100 mg aspirin

Drug: aspirinDrug: clopidogrel

2

ACTIVE COMPARATOR

150 mg clopidogrel + 100 mg aspirin

Drug: aspirinDrug: clopidogrel

Interventions

aspirinDRUG

100 mg aspirin

12
clopidogrelDRUG

75 mg (Arm 1) and 150 mg (Arm 2)

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • angioplasty and stenting for peripheral, coronary or carotid artery disease

You may not qualify if:

  • known aspirin or clopidogrel intolerance
  • therapy with vitamin K antagonists (warfarin, phenprocoumon, acenocoumarol)
  • treatment with ticlopidine, dipyridamol or nonsteroidal antiinflammatory drugs
  • family or personal history of bleeding disorders
  • malignant paraproteinemias
  • myeloproliferative disorders
  • heparin-induced thrombocytopenia
  • severe hepatic failure
  • known qualitative defects in thrombocyte function
  • major surgical procedure within one week before enrollment
  • platelet count \< 100.000 or \> 450.000/µl
  • hemoglobin \< 8 g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Angiology, Department of Internal Medicine II, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Christoph W. Kopp, M.D.

    Division of Angiology/ Department of Internal Medicine II/ Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 10, 2009

Study Start

May 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

AU(1)