Effect of Ticagrelor on Endothelial Function
Primary Purpose
Coronary Artery Disease, Endothelial Function
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
clopidogrel
Ticagrelor
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery disease, endothelial function, antiplatelet agent
Eligibility Criteria
Inclusion Criteria:
- Age>18 years old
- At least two cardiovascular risk factors
- Demonstrated endothelial dysfunction
- Evidence of coronary artery disease
Exclusion Criteria:
- Second (II) or third (III) degree heart block without a pacemaker
- Known active pathological bleeding, history of stroke, or bleeding diathesis
- Dyspnea classified as NYHA class III-IV
- Need for oral anticoagulants
- Clinically significant valvular heart disease
- Any concurrent life threatening condition with a life expectancy less than 1 year
- History or evidence of drug or alcohol abuse within the last 12 months
- 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
- 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.
- Latex allergy
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- 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.
- Patients who are also taking strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
- patients taking antiplatelet medications which cannot be stopped
- severe liver disease
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
clopidogrel-ticagrelor
ticagrelor-clopidogrel
Arm Description
21 days clopidogrel followed by 21 days ticagrelor
ticagrelor for 21 days followed by clopidogrel for 21 days
Outcomes
Primary Outcome Measures
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication
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
Acute change in endothelial function
Endothelial function assessed 2 hours post ticagrelor
Full Information
NCT ID
NCT01805596
First Posted
March 1, 2013
Last Updated
October 4, 2016
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01805596
Brief Title
Effect of Ticagrelor on Endothelial Function
Official Title
Effect of Ticagrelor on Endothelial Function
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Endothelial Function
Keywords
coronary artery disease, endothelial function, antiplatelet agent
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
clopidogrel-ticagrelor
Arm Type
Experimental
Arm Description
21 days clopidogrel followed by 21 days ticagrelor
Arm Title
ticagrelor-clopidogrel
Arm Type
Experimental
Arm Description
ticagrelor for 21 days followed by clopidogrel for 21 days
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Other Intervention Name(s)
Plavix
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilinta
Primary Outcome Measure Information:
Title
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Acute change in endothelial function
Description
Endothelial function assessed 2 hours post ticagrelor
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age>18 years old
At least two cardiovascular risk factors
Demonstrated endothelial dysfunction
Evidence of coronary artery disease
Exclusion Criteria:
Second (II) or third (III) degree heart block without a pacemaker
Known active pathological bleeding, history of stroke, or bleeding diathesis
Dyspnea classified as NYHA class III-IV
Need for oral anticoagulants
Clinically significant valvular heart disease
Any concurrent life threatening condition with a life expectancy less than 1 year
History or evidence of drug or alcohol abuse within the last 12 months
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
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.
Latex allergy
History of noncompliance to medical regimens or unwillingness to comply with the study protocol
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.
Patients who are also taking strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
patients taking antiplatelet medications which cannot be stopped
severe liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28449783
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.
Results Reference
derived
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Effect of Ticagrelor on Endothelial Function
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