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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ticagrelor

180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

Ticagrelor 90mg twice daily for 5 weeks

Prasugrel

60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor

Group Type ACTIVE_COMPARATOR

Prasugrel

Intervention Type DRUG

Prasugrel 10mg once daily for 5 weeks

Interventions

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Ticagrelor

Ticagrelor 90mg twice daily for 5 weeks

Intervention Type DRUG

Prasugrel

Prasugrel 10mg once daily for 5 weeks

Intervention Type DRUG

Other Intervention Names

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Brilinta Effient

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No