Effect of Ticagrelor on Endothelial Function

NCT01805596 | Completed Phase 3

• 1 other identifier: ENTC-18129
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Endothelial Function

Keywords

coronary artery disease; endothelial function; antiplatelet agent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acute change in endothelial function

  2 hours

Study Arms (2)

clopidogrel-ticagrelor

EXPERIMENTAL

21 days clopidogrel followed by 21 days ticagrelor

Drug: clopidogrel; Drug: Ticagrelor

ticagrelor-clopidogrel

EXPERIMENTAL

ticagrelor for 21 days followed by clopidogrel for 21 days

Drug: clopidogrel; Drug: Ticagrelor

Interventions

clopidogrel DRUG

Also known as: Plavix

clopidogrel-ticagrelor; ticagrelor-clopidogrel

Ticagrelor DRUG

Also known as: Brilinta

clopidogrel-ticagrelor; ticagrelor-clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years old
• At least two cardiovascular risk factors
• Demonstrated endothelial dysfunction
• Evidence of coronary artery disease

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

• 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.

  PMID: 28449783 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Shahar Lavi, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 6, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

CA (1)