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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

Sponsor
Korea University Anam Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02487732
Collaborator
AstraZeneca (Industry)
60
Enrollment
1
Location
2
Arms
18.1
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in circulating number of endothelial progenitor cells [Expected average of 5 weeks]

    2. Changes in brachial artery flow mediated dilation [Expected average of 5 weeks]

    Secondary Outcome Measures

    1. Composite measure of brachial-ankle pulse wave velocity, and augmentation index. [Expected average of 5 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Anam Hospital Seoul Korea, Republic of 136-705

    Sponsors and Collaborators

    • Korea University Anam Hospital
    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soon Jun Hong, Associate Professor, Korea University Anam Hospital
    ClinicalTrials.gov Identifier:
    NCT02487732
    Other Study ID Numbers:
    • Adenosine diphosphate blockers
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    Apr 25, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Soon Jun Hong, Associate Professor, Korea University Anam Hospital
    Diabetic Patients With Non-ST Elevation
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Ticagrelor
    Prasugrel Hydrochloride

    Study Results

    No Results Posted as of Apr 25, 2019