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

April 24, 2019 updated by: Soon Jun Hong, Korea University Anam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ticagrelor
180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel
Drug: Ticagrelor
Ticagrelor 90mg twice daily for 5 weeks
Other Names:
  • Brilinta
Active Comparator: Prasugrel
60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor
Drug: Prasugrel
Prasugrel 10mg once daily for 5 weeks
Other Names:
  • Effient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in circulating number of endothelial progenitor cells
Time Frame: Expected average of 5 weeks
Expected average of 5 weeks
Changes in brachial artery flow mediated dilation
Time Frame: Expected average of 5 weeks
Expected average of 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite measure of brachial-ankle pulse wave velocity, and augmentation index.
Time Frame: Expected average of 5 weeks
Expected average of 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 27, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adenosine diphosphate blockers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on Ticagrelor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe