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Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents

NCT ID: NCT00589862

Last Updated: 2015-11-30

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-07-31

Brief Summary

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It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Plavix (Clopidogrel)

Intervention Type DRUG

150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified

Interventions

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Plavix (Clopidogrel)

150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Required Coronary Artery Angioplasty with a drug-eluting stent deployment

Exclusion Criteria

* The last drug-eluting stent placed greater than 2 weeks prior
* Aspirin or Plavix (Clopidogrel) allergy or contraindication
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Daniel Hilleman, PharmD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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07-14622

Identifier Type: -

Identifier Source: secondary_id

07-14622

Identifier Type: -

Identifier Source: org_study_id