Effect of Ticagrelor on Endothelial Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01805596
First received: March 1, 2013
Last updated: June 6, 2014
Last verified: June 2014

March 1, 2013
June 6, 2014
April 2013
June 2015   (final data collection date for primary outcome measure)
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication [ Time Frame: 21 days ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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
    Interventions:
    • Drug: clopidogrel
    • Drug: Ticagrelor
  • Experimental: ticagrelor-clopidogrel
    ticagrelor for 21 days followed by clopidogrel for 21 days
    Interventions:
    • 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.
 
Recruiting
45
June 2015
June 2015   (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
Both
18 Years and older
No
Contact: Shahar Lavi, MD 519-663-3611 shahar.lavi@lhsc.on.ca
Contact: Sabrina D'Alfonso, MSc 519-685-8500 ext 34807 sabrina.dalfonso@lhsc.on.ca
Canada
 
NCT01805596
ENTC-18129
No
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
June 2014

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