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Effect of Ticagrelor on Endothelial Function

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ClinicalTrials.gov Identifier: NCT01805596
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : October 5, 2016
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute

March 1, 2013
March 6, 2013
October 5, 2016
April 2013
February 2016   (Final data collection date for primary outcome measure)
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01805596 on ClinicalTrials.gov Archive Site
Acute change in endothelial function [ Time Frame: 2 hours ]
Endothelial function assessed 2 hours post ticagrelor
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Not Provided
Not Provided
Effect of Ticagrelor on Endothelial Function
Effect of Ticagrelor on Endothelial Function
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Endothelial Function
  • Drug: clopidogrel
    Other Name: Plavix
  • Drug: Ticagrelor
    Other Name: Brilinta
  • Experimental: clopidogrel-ticagrelor
    21 days clopidogrel followed by 21 days ticagrelor
    • Drug: clopidogrel
    • Drug: Ticagrelor
  • Experimental: ticagrelor-clopidogrel
    ticagrelor for 21 days followed by clopidogrel for 21 days
    • Drug: clopidogrel
    • Drug: Ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2016
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Shahar Lavi, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Shahar Lavi, MD London Health Sciences Centre
Lawson Health Research Institute
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP