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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Endothelial Function
• Intervention / Treatment: Drug: Ticagrelor; Drug: clopidogrel

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: clopidogrel-ticagrelor; 21 days clopidogrel followed by 21 days ticagrelor	Drug: Ticagrelor; Other Names: Brilinta; Drug: clopidogrel; Other Names: Plavix
Experimental: ticagrelor-clopidogrel; ticagrelor for 21 days followed by clopidogrel for 21 days	Drug: Ticagrelor; Other Names: Brilinta; Drug: clopidogrel; Other Names: Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute change in endothelial function	Endothelial function assessed 2 hours post ticagrelor	2 hours

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Shahar Lavi, MD, London Health Sciences Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 6, 2013

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: coronary artery disease; endothelial function; antiplatelet agent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: ENTC-18129