Clinical trial NCT02487732: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Diabetic Patients With Non-ST Elevation
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2015-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Changes in circulating number of endothelial progenitor cells
timeFrame: Expected average of 5 weeks
measure: Changes in brachial artery flow mediated dilation
timeFrame: Expected average of 5 weeks
Secondary outcomes:
measure: Composite measure of brachial-ankle pulse wave velocity, and augmentation index.
timeFrame: Expected average of 5 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
citation: Jeong HS, Hong SJ, Cho SA, Kim JH, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW, Lim DS. Comparison of Ticagrelor Versus Prasugrel for Inflammation, Vascular Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST-Segment Elevation Acute Coronary Syndrome Requiring Coronary Stenting: A Prospective, Randomized, Crossover Trial. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1646-1658. doi: 10.1016/j.jcin.2017.05.064.