NCT02487732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

June 27, 2015

Last Update Submit

April 24, 2019

Conditions

Acute Coronary Syndrome

Keywords

Diabetic Patients With Non-ST Elevation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    Expected average of 5 weeks

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

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

Drug: Ticagrelor

Prasugrel

ACTIVE COMPARATOR

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

Drug: Prasugrel

Interventions

TicagrelorDRUG

Ticagrelor 90mg twice daily for 5 weeks

Also known as: Brilinta
Ticagrelor
PrasugrelDRUG

Prasugrel 10mg once daily for 5 weeks

Also known as: Effient
Prasugrel

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28838475DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

TicagrelorPrasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2015

First Posted

July 1, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2016

Study Completion

January 1, 2017

Last Updated

April 25, 2019

Record last verified: 2019-04

Locations

KR(1)