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

Condition(s) targeted: Coronary Artery Disease

Intervention: Plavix (Clopidogrel) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Creighton University

Official(s) and/or principal investigator(s):
Daniel Hilleman, PharmD, Principal Investigator, Affiliation: Creighton University

Overall contact:
Daniel Hilleman, PharmD, Phone: 402-280-4288, Email: hilleman@creighton.edu

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.

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Primary outcome: 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

Secondary outcome:

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

to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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

Daniel Hilleman, PharmD, Phone: 402-280-4288, Email: hilleman@creighton.edu

Creighton University Medical Center, Omaha, Nebraska 68131, United States; Recruiting
Daniel Hilleman, PharmD, Phone: 402-280-4288, Email: hilleman@creighton.edu
Daniel Hilleman, PharmD, Principal Investigator

Starting date: October 2007
Last updated: January 30, 2008