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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This study has been withdrawn prior to enrollment.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

December 28, 2007
July 29, 2011
October 2007
July 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00589862 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Drug: Plavix (Clopidogrel)
150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified
Experimental: 1
Intervention: Drug: Plavix (Clopidogrel)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
200
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589862
07-14622, 07-14622
Not Provided
Daniel Hilleman, PharmD, Creighton University
Creighton University
Not Provided
Principal Investigator: Daniel Hilleman, PharmD Creighton University
Creighton University
July 2011

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