Effect of Ticagrelor on Endothelial Function

Phase 3

Completed

• Conditions: Endothelial Function; Coronary Artery Disease
• Interventions: Drug: clopidogrel; Drug: Ticagrelor

• Registration Number: NCT01805596
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Study Start: 2013-04
• Primary Completion: 2016-02
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
clopidogrel-ticagrelor	clopidogrel	21 days clopidogrel followed by 21 days ticagrelor
clopidogrel-ticagrelor	Ticagrelor	21 days clopidogrel followed by 21 days ticagrelor
ticagrelor-clopidogrel	clopidogrel	ticagrelor for 21 days followed by clopidogrel for 21 days
ticagrelor-clopidogrel	Ticagrelor	ticagrelor for 21 days followed by clopidogrel for 21 days

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication	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 Outcome Measures

Name	Time	Method
Acute change in endothelial function	2 hours	Endothelial function assessed 2 hours post ticagrelor

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada