Resistance to Antithrombotic Therapy (Vienna REACT)

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Medical University of Vienna

Status

Completed

Conditions

Angioplasty
Atherosclerosis

Treatments

Drug: clopidogrel
Drug: aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00858715
Vienna REACT

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 2 patient groups

1
Active Comparator group
Description:
75 mg clopidogrel + 100 mg aspirin
Treatment:
Drug: aspirin
Drug: clopidogrel
2
Active Comparator group
Description:
150 mg clopidogrel + 100 mg aspirin
Treatment:
Drug: aspirin
Drug: clopidogrel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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