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Resistance to Antithrombotic Therapy (Vienna REACT)

Primary Purpose

Atherosclerosis, Angioplasty

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

aspirin

clopidogrel

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Clopidogrel, Aspirin, Antithrombotic therapy, Platelet function testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

75 mg clopidogrel + 100 mg aspirin

150 mg clopidogrel + 100 mg aspirin

Outcomes

Primary Outcome Measures

Occurence of major adverse cardiovascular events (MACE)

Secondary Outcome Measures

Full Information

NCT ID

NCT00858715

First Posted

March 9, 2009

Last Updated

December 11, 2012

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00858715

Brief Title

Resistance to Antithrombotic Therapy

Acronym

Vienna REACT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, Angioplasty

Keywords

Clopidogrel, Aspirin, Antithrombotic therapy, Platelet function testing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

75 mg clopidogrel + 100 mg aspirin

Arm Title

Arm Type

Active Comparator

Arm Description

150 mg clopidogrel + 100 mg aspirin

Intervention Type

Drug

Intervention Name(s)

aspirin

Intervention Description

100 mg aspirin

Intervention Type

Drug

Intervention Name(s)

clopidogrel

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurence of major adverse cardiovascular events (MACE)

Time Frame

3 months

Title

Occurence of major adverse cardiovascular events (MACE)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph W. Kopp, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Resistance to Antithrombotic Therapy

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