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OpenTrials
Completed

NCT Number: NCT01805596

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Other names: Plavix

Ticagrelor

Drug

Other names: Brilinta

Primary outcomes

  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 outcomes

  1. Acute change in endothelial function

    Time frame: 2 hours

    Endothelial function assessed 2 hours post ticagrelor

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2013
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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