Effect of Ticagrelor on Endothelial Function

Coronary Artery Disease Clinical Trial

Official title:

Effect of Ticagrelor on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805596
• Other study ID #: ENTC-18129
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2013
• Last updated: October 4, 2016
• Start date: April 2013
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Endothelial Function
• Myocardial Ischemia

Intervention

Drug:
• clopidogrel

• Ticagrelor

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Acute change in endothelial function	Endothelial function assessed 2 hours post ticagrelor	2 hours	No