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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Recruitment Status : Withdrawn (Failure to secure adequate funding)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:

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Plavix (Clopidogrel) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Plavix (Clopidogrel)
150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589862


Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Daniel Hilleman, PharmD Creighton University
More Information

Responsible Party: Daniel Hilleman, PharmD, Creighton University
ClinicalTrials.gov Identifier: NCT00589862     History of Changes
Other Study ID Numbers: 07-14622
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Keywords provided by Creighton University:
Drug Eluting Stents
Clopidogrel Resistance
Aspirin Resistance

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs