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

Primary Purpose

Coronary Artery Disease

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Plavix (Clopidogrel)

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Eluting Stents, Clopidogrel Resistance, Aspirin Resistance

Eligibility Criteria

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

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

Sites / Locations

Creighton University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment

Secondary Outcome Measures

to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance

to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).

Full Information

NCT ID

NCT00589862

First Posted

December 28, 2007

Last Updated

November 27, 2015

Sponsor

Creighton University

1. Study Identification

Unique Protocol Identification Number

NCT00589862

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Failure to secure adequate funding

Study Start Date

October 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Creighton University

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Coronary Artery Disease

Keywords

Drug Eluting Stents, Clopidogrel Resistance, Aspirin Resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Plavix (Clopidogrel)

Intervention Description

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

Primary Outcome Measure Information:

Title

to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment

Time Frame

3 month intervals up to 12 months

Secondary Outcome Measure Information:

Title

to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance

Time Frame

3 month intervals up to 12 months

Title

to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).

Time Frame

3 month intervals up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Hilleman, PharmD

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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