Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting

Study Overview
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Brief Summary
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To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness.

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Prasugrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70 Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure) Exclusion Criteria: Hypersensitivity to ticagrelor, prasugrel or any of the excipients No prior use of either ticagrelor or prasugrel within a month prior to randomization. History of intracranial bleeding at any time Active pathologic bleeding Hemoglobin A1c >9% Type 1 diabetes Decreased serum platelet level (< 100,000/uL) Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin Gastrointestinal bleed within the past 6 months, or major surgery within 30 days Renal failure requiring dialysis or anticipated need for dialysis during the course of the study Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study Involvement in the planning and/or conduct of the study Left ventricular ejection fraction < 40% Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase > twice the upper limit) Gastrointestinal disorder such as Crohn's disease Alcohol abuse Steroid or hormone replacement therapy Serum creatinine > 2.0 mg/dL. Prior history of CVA or stroke Body weight < 60 kg Life expectancy less than a year Known pregnancy, breast-feeding, or intend to become pregnant during the study period

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ticagrelor<br>180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel | Drug: Ticagrelor<br>* Ticagrelor 90mg twice daily for 5 weeks<br>* Other names: Brilinta;|
| Active Comparator: Prasugrel<br>60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor | Drug: Prasugrel<br>* Prasugrel 10mg once daily for 5 weeks<br>* Other names: Effient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in circulating number of endothelial progenitor cells |  | Expected average of 5 weeks | 
| Changes in brachial artery flow mediated dilation |  | Expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of brachial-ankle pulse wave velocity, and augmentation index. |  | Expected average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Patients With Non-ST Elevation