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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Endothelial Function
Drug: clopidogrel
Drug: Ticagrelor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Ticagrelor on Endothelial Function

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 45
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clopidogrel-ticagrelor
21 days clopidogrel followed by 21 days ticagrelor
Drug: clopidogrel
Other Name: Plavix
Drug: Ticagrelor
Other Name: Brilinta
Experimental: ticagrelor-clopidogrel
ticagrelor for 21 days followed by clopidogrel for 21 days
Drug: clopidogrel
Other Name: Plavix
Drug: Ticagrelor
Other Name: Brilinta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805596

Contacts
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

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A5A5
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   
Principal Investigator: Shahar Lavi, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shahar Lavi, MD London Health Sciences Centre
  More Information

No publications provided

Responsible Party: Shahar Lavi, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01805596     History of Changes
Other Study ID Numbers: ENTC-18129
Study First Received: March 1, 2013
Last Updated: June 6, 2014
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
coronary artery disease
endothelial function
antiplatelet agent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Ticagrelor
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014