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

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487732
• Other study ID #: Adenosine diphosphate blockers
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: April 2019
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Ticagrelor
Ticagrelor 90mg twice daily for 5 weeks
• Prasugrel
Prasugrel 10mg once daily for 5 weeks

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in circulating number of endothelial progenitor cells		Expected average of 5 weeks
Primary	Changes in brachial artery flow mediated dilation		Expected average of 5 weeks
Secondary	Composite measure of brachial-ankle pulse wave velocity, and augmentation index.		Expected average of 5 weeks