Resistance to Antithrombotic Therapy

Atherosclerosis Clinical Trial

— Vienna REACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858715
• Other study ID #: Vienna REACT
• 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

• Angioplasty
• Atherosclerosis

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