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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Anam Hospital
• Collaborator: AstraZeneca
• Treatments: Prasugrel Hydrochloride; Ticagrelor

Criteria

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