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OpenTrials
Completed

NCT Number: NCT02487732

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

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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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

Ticagrelor 90mg twice daily for 5 weeks

Other names: Brilinta

Prasugrel

Drug

Prasugrel 10mg once daily for 5 weeks

Other names: Effient

Primary outcomes

  1. Changes in circulating number of endothelial progenitor cells

    Time frame: Expected average of 5 weeks

  2. Changes in brachial artery flow mediated dilation

    Time frame: Expected average of 5 weeks

Secondary outcomes

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

    Time frame: Expected average of 5 weeks

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • AstraZeneca

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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