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

This study has been withdrawn prior to enrollment.

(Failure to secure adequate funding)

Sponsor:

Information provided by:

Creighton University

ClinicalTrials.gov Identifier:

NCT00589862

First received: December 28, 2007

Last updated: July 29, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 28, 2007

Last Updated Date

July 29, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

to evaluate the frequency of aspirin and 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 ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00589862 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

to assess if a clopidogrel dose increase in patients with resistance to both aspirin and clopidogrel is effective in overcoming antiplatelet drug resistance [ Time Frame: 3 month intervals up to 12 months ] [ Designated as safety issue: Yes ]
to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in clopidogrel [ Time Frame: 3 month intervals up to 12 months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: Plavix (Clopidogrel)

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

Study Arm (s)

Experimental: 1

Intervention: Drug: Plavix (Clopidogrel)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

200

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00589862

Other Study ID Numbers ^ICMJE

07-14622, 07-14622

Has Data Monitoring Committee

Not Provided

Responsible Party

Daniel Hilleman, PharmD, Creighton University

Study Sponsor ^ICMJE

Creighton University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Daniel Hilleman, PharmD

Creighton University

Information Provided By

Creighton University

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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