Effect of Ticagrelor on Endothelial Function

Study Overview
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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.

Official Title
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Effect of Ticagrelor on Endothelial Function

Conditions
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Coronary Artery Disease, Endothelial Function

Intervention / Treatment
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* Drug: clopidogrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clopidogrel-ticagrelor<br>21 days clopidogrel followed by 21 days ticagrelor | Drug: clopidogrel<br> <br> * Other names: Plavix;Drug: Ticagrelor<br> <br> * Other names: Brilinta;|
| Experimental: ticagrelor-clopidogrel<br>ticagrelor for 21 days followed by clopidogrel for 21 days | Drug: clopidogrel<br> <br> * Other names: Plavix;Drug: Ticagrelor<br> <br> * Other names: Brilinta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute change in endothelial function | Endothelial function assessed 2 hours post ticagrelor | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, endothelial function, antiplatelet agent