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Resistance to Antithrombotic Therapy

NCT ID: NCT00858715

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis Angioplasty

Keywords

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Clopidogrel Aspirin Antithrombotic therapy Platelet function testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

75 mg clopidogrel + 100 mg aspirin

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

100 mg aspirin

clopidogrel

Intervention Type DRUG

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

2

150 mg clopidogrel + 100 mg aspirin

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

100 mg aspirin

clopidogrel

Intervention Type DRUG

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

Interventions

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aspirin

100 mg aspirin

Intervention Type DRUG

clopidogrel

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Christoph W. Kopp

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph W. Kopp, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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Vienna REACT

Identifier Type: -

Identifier Source: org_study_id