Clinical trial NCT01805596: Effect of Ticagrelor on Endothelial Function
Official title: Effect of Ticagrelor on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Endothelial Function
Keywords: coronary artery disease
endothelial function
antiplatelet agent
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Endothelial Function after 21 days of antiplatelet medication
timeFrame: 21 days
Secondary outcomes:
measure: Acute change in endothelial function
timeFrame: 2 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Shahar Lavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alemayehu M, Kim RB, Lavi R, Gong I, D'Alfonso S, Mansell SE, Wall S, Lavi S. Effect of Ticagrelor Versus Clopidogrel on Vascular Reactivity. J Am Coll Cardiol. 2017 May 2;69(17):2246-2248. doi: 10.1016/j.jacc.2017.02.048. No abstract available.