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Resistance to Antithrombotic Therapy (Vienna REACT)

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ClinicalTrials.gov Identifier: NCT00858715
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
Christoph W. Kopp, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Angioplasty Drug: aspirin Drug: clopidogrel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT
Study Start Date : May 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: 1
75 mg clopidogrel + 100 mg aspirin
Drug: aspirin
100 mg aspirin

Drug: clopidogrel
75 mg (Arm 1) and 150 mg (Arm 2)

Active Comparator: 2
150 mg clopidogrel + 100 mg aspirin
Drug: aspirin
100 mg aspirin

Drug: clopidogrel
75 mg (Arm 1) and 150 mg (Arm 2)




Primary Outcome Measures :
  1. Occurence of major adverse cardiovascular events (MACE) [ Time Frame: 3 months ]
  2. Occurence of major adverse cardiovascular events (MACE) [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858715


Locations
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Austria
Division of Angiology, Department of Internal Medicine II, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Christoph W. Kopp, M.D. Division of Angiology/ Department of Internal Medicine II/ Medical University of Vienna

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Responsible Party: Christoph W. Kopp, Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00858715     History of Changes
Other Study ID Numbers: Vienna REACT
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Christoph W. Kopp, Medical University of Vienna:
Clopidogrel
Aspirin
Antithrombotic therapy
Platelet function testing

Additional relevant MeSH terms:
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Clopidogrel
Platelet Aggregation Inhibitors
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents