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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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ticagrelor

Prasugrel

About this trial

This is an interventional other trial for Acute Coronary Syndrome focused on measuring Diabetic Patients With Non-ST Elevation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70
Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)

Exclusion Criteria:

Hypersensitivity to ticagrelor, prasugrel or any of the excipients
No prior use of either ticagrelor or prasugrel within a month prior to randomization.
History of intracranial bleeding at any time
Active pathologic bleeding
Hemoglobin A1c >9%
Type 1 diabetes
Decreased serum platelet level (< 100,000/uL)
Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
Gastrointestinal bleed within the past 6 months, or major surgery within 30 days
Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
Involvement in the planning and/or conduct of the study
Left ventricular ejection fraction < 40%
Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase > twice the upper limit)
Gastrointestinal disorder such as Crohn's disease
Alcohol abuse
Steroid or hormone replacement therapy
Serum creatinine > 2.0 mg/dL.
Prior history of CVA or stroke
Body weight < 60 kg
Life expectancy less than a year
Known pregnancy, breast-feeding, or intend to become pregnant during the study period

Sites / Locations

Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ticagrelor

Prasugrel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in circulating number of endothelial progenitor cells

Changes in brachial artery flow mediated dilation

Secondary Outcome Measures

Composite measure of brachial-ankle pulse wave velocity, and augmentation index.

Full Information

NCT ID

NCT02487732

First Posted

June 27, 2015

Last Updated

April 24, 2019

Sponsor

Korea University Anam Hospital

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02487732

Brief Title

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

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korea University Anam Hospital

Collaborators

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Diabetic Patients With Non-ST Elevation

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor

Arm Type

Active Comparator

Arm Description

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

Arm Title

Prasugrel

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

Brilinta

Intervention Description

Ticagrelor 90mg twice daily for 5 weeks

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Other Intervention Name(s)

Effient

Intervention Description

Prasugrel 10mg once daily for 5 weeks

Primary Outcome Measure Information:

Title

Changes in circulating number of endothelial progenitor cells

Time Frame

Expected average of 5 weeks

Title

Changes in brachial artery flow mediated dilation

Time Frame

Expected average of 5 weeks

Secondary Outcome Measure Information:

Title

Composite measure of brachial-ankle pulse wave velocity, and augmentation index.

Time Frame

Expected average of 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of informed consent prior to any study specific procedures Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70 Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure) Exclusion Criteria: Hypersensitivity to ticagrelor, prasugrel or any of the excipients No prior use of either ticagrelor or prasugrel within a month prior to randomization. History of intracranial bleeding at any time Active pathologic bleeding Hemoglobin A1c >9% Type 1 diabetes Decreased serum platelet level (< 100,000/uL) Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin Gastrointestinal bleed within the past 6 months, or major surgery within 30 days Renal failure requiring dialysis or anticipated need for dialysis during the course of the study Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study Involvement in the planning and/or conduct of the study Left ventricular ejection fraction < 40% Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase > twice the upper limit) Gastrointestinal disorder such as Crohn's disease Alcohol abuse Steroid or hormone replacement therapy Serum creatinine > 2.0 mg/dL. Prior history of CVA or stroke Body weight < 60 kg Life expectancy less than a year Known pregnancy, breast-feeding, or intend to become pregnant during the study period

Facility Information:

Facility Name

Korea University Anam Hospital

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

28838475

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.

Results Reference

derived

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