Effect of Ticagrelor on Endothelial Function

NCT ID: NCT01805596

Last Updated: 2016-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease Endothelial Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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clopidogrel-ticagrelor

21 days clopidogrel followed by 21 days ticagrelor

Group Type EXPERIMENTAL

clopidogrel

Intervention Type DRUG

Ticagrelor

Intervention Type DRUG

ticagrelor-clopidogrel

ticagrelor for 21 days followed by clopidogrel for 21 days

Group Type EXPERIMENTAL

clopidogrel

Intervention Type DRUG

Ticagrelor

Intervention Type DRUG

Interventions

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clopidogrel

Intervention Type DRUG

Ticagrelor

Intervention Type DRUG

Other Intervention Names

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Plavix Brilinta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Shahar Lavi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shahar Lavi, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 28449783 (View on PubMed)

Other Identifiers

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ENTC-18129

Identifier Type: -

Identifier Source: org_study_id

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