Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents - Full Text View

Sponsor:	Creighton University
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00589862

Purpose

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	Intervention	Phase
Coronary Artery Disease	Drug: Plavix (Clopidogrel)	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Coronary Artery Disease

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Creighton University:

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 [ Time Frame: 3 month intervals up to 12 months ] [ Designated as safety issue: Yes ]

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 [ 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 ]

Estimated Enrollment:	200
Study Start Date:	October 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Plavix (Clopidogrel) 150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Daniel Hilleman, PharmD, Creighton University
ClinicalTrials.gov Identifier:	NCT00589862 History of Changes
Other Study ID Numbers:	07-14622, 07-14622
Study First Received:	December 28, 2007
Last Updated:	July 29, 2011
Health Authority:	United States: Institutional Review Board

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

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012