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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00858715
Other study ID # Vienna REACT
Secondary ID
Status Completed
Phase N/A
First received March 9, 2009
Last updated December 11, 2012
Start date May 2008
Est. completion date May 2012

Study information

Verified date December 2012
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Division of Angiology, Department of Internal Medicine II, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurence of major adverse cardiovascular events (MACE) 3 months No
Primary Occurence of major adverse cardiovascular events (MACE) 12 months No
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