Coronary Artery Disease
Conditions
Keywords
Drug Eluting Stents, Clopidogrel Resistance, Aspirin Resistance
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.
Interventions
DRUGPlavix (Clopidogrel)
150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified
Sponsors
Creighton University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 3 month intervals up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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). | 3 month intervals up to 12 months |
Countries
United States
Outcome results
None listed