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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor; Drug: Prasugrel

• Registration Number: NCT02487732
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-27
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-01
• Primary Completion: 2016-08
• Study Completion: 2017-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel
Prasugrel	Prasugrel	60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Composite measure of brachial-ankle pulse wave velocity, and augmentation index.	Expected average of 5 weeks

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of