Coronary Artery Disease, Endothelial Function
Conditions
Keywords
coronary artery disease, endothelial function, antiplatelet agent
Brief summary
This study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels.
Interventions
DRUGclopidogrel
DRUGTicagrelor
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\>18 years old 2. At least two cardiovascular risk factors 3. Demonstrated endothelial dysfunction 4. Evidence of coronary artery disease
Exclusion criteria
1. Second (II) or third (III) degree heart block without a pacemaker 2. Known active pathological bleeding, history of stroke, or bleeding diathesis 3. Dyspnea classified as NYHA class III-IV 4. Need for oral anticoagulants 5. Clinically significant valvular heart disease 6. Any concurrent life threatening condition with a life expectancy less than 1 year 7. History or evidence of drug or alcohol abuse within the last 12 months 8. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 9. History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs. 10. Latex allergy 11. History of noncompliance to medical regimens or unwillingness to comply with the study protocol 12. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Positive pregnancy test, breast feeding women or women of child bearing potential not using highly effective methods of contraception. 13. Patients who are also taking strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir) 14. patients taking antiplatelet medications which cannot be stopped 15. severe liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Endothelial Function after 21 days of antiplatelet medication | 21 days | The change in endothelial function from baseline will be assessed after 21 days of clopidogrel; the change in endothelial function from baseline will be assessed after 21 days of ticagrelor. This will be measured using RH-PAT units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute change in endothelial function | 2 hours | Endothelial function assessed 2 hours post ticagrelor |
Countries
Canada
Outcome results
None listed