Effect of Ticagrelor on Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Endothelial Function Drug: clopidogrel Drug: Ticagrelor Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Ticagrelor on Endothelial Function
Study Start Date : April 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Acute change in endothelial function [ Time Frame: 2 hours ]
    Endothelial function assessed 2 hours post ticagrelor

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01805596

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

Responsible Party: Shahar Lavi, Principal Investigator, Lawson Health Research Institute Identifier: NCT01805596     History of Changes
Other Study ID Numbers: ENTC-18129
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Shahar Lavi, 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
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors