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

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ClinicalTrials.gov Identifier: NCT00589862
Recruitment Status : Withdrawn (Failure to secure adequate funding)
First Posted : January 10, 2008
Last Update Posted : November 30, 2015
Sponsor:
Information provided by:
Creighton University

Tracking Information
First Submitted Date  ICMJE December 28, 2007
First Posted Date  ICMJE January 10, 2008
Last Update Posted Date November 30, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2008)
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: November 27, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2008)
200
Actual Study Completion Date  ICMJE July 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00589862
Other Study ID Numbers  ICMJE 07-14622
07-14622
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
PRS Account Creighton University
Verification Date November 2015

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