Text Size

Resistance to Antithrombotic Therapy (Vienna REACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph W. Kopp, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00858715
First received: March 9, 2009
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Atherosclerosis
Angioplasty
 Drug: aspirin
Drug: clopidogrel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Occurence of major adverse cardiovascular events (MACE) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Occurence of major adverse cardiovascular events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858715

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

No publications provided

Responsible Party: Christoph W. Kopp, Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00858715     History of Changes
Other Study ID Numbers: Vienna REACT
Study First Received: March 9, 2009
Last Updated: December 11, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Clopidogrel
Aspirin
Antithrombotic therapy
Platelet function testing

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

ClinicalTrials.gov processed this record on June 17, 2013