Acute Coronary Syndrome
Conditions
Keywords
Diabetic Patients With Non-ST Elevation
Brief summary
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.
Interventions
DRUGTicagrelor
Ticagrelor 90mg twice daily for 5 weeks
DRUGPrasugrel
Prasugrel 10mg once daily for 5 weeks
Sponsors
AstraZeneca
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures 2. Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70 3. Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)
Exclusion criteria
1. Hypersensitivity to ticagrelor, prasugrel or any of the excipients 2. No prior use of either ticagrelor or prasugrel within a month prior to randomization. 3. History of intracranial bleeding at any time 4. Active pathologic bleeding 5. Hemoglobin A1c \>9% 6. Type 1 diabetes 7. Decreased serum platelet level (\< 100,000/uL) 8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin 9. Gastrointestinal bleed within the past 6 months, or major surgery within 30 days 10. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study 11. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study 12. Involvement in the planning and/or conduct of the study 13. Left ventricular ejection fraction \< 40% 14. Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit) 15. Gastrointestinal disorder such as Crohn's disease 16. Alcohol abuse 17. Steroid or hormone replacement therapy 18. Serum creatinine \> 2.0 mg/dL. 19. Prior history of CVA or stroke 20. Body weight \< 60 kg 21. Life expectancy less than a year 22. Known pregnancy, breast-feeding, or intend to become pregnant during the study period
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Composite measure of brachial-ankle pulse wave velocity, and augmentation index. | Expected average of 5 weeks |
Countries
South Korea
Outcome results
None listed