This trial is active, not recruiting.

Condition acute coronary syndrome
Treatments ticagrelor, prasugrel
Phase phase 4
Sponsor Korea University Anam Hospital
Collaborator AstraZeneca
Start date July 2015
End date February 2016
Trial size 60 participants
Trial identifier NCT02487732, Adenosine diphosphate blockers


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
(Active Comparator)
180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel
ticagrelor Brilinta
Ticagrelor 90mg twice daily for 5 weeks
(Active Comparator)
60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor
prasugrel Effient
Prasugrel 10mg once daily for 5 weeks

Primary Outcomes

Changes in circulating number of endothelial progenitor cells
time frame: Expected average of 5 weeks
Changes in brachial artery flow mediated dilation
time frame: Expected average of 5 weeks

Secondary Outcomes

Composite measure of brachial-ankle pulse wave velocity, and augmentation index.
time frame: Expected average of 5 weeks

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Korea University Anam Hospital.