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Completed

NCT Number: NCT00858715

Resistance to Antithrombotic Therapy

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.

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Key information

Conditions

Atherosclerosis Angioplasty Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

100 mg aspirin

clopidogrel

Drug

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

Primary outcomes

  1. Occurence of major adverse cardiovascular events (MACE)

    Time frame: 3 months

  2. Occurence of major adverse cardiovascular events (MACE)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT

Acronym: Vienna REACT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 10, 2009
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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