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Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

Sponsor
Li Bo (Other)
Overall Status
Completed
CT.gov ID
NCT02655757
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
15.3
Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion in Patients With Coronary Heart Disease Complicated With Type 2 Diabetes
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Feb 2, 2017
Actual Study Completion Date :
Mar 10, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sitagliptin

Sitagliptin 100mg QD

Drug: Sitagliptin
5 mg, 1 tablet per day for 12 months
Other Names:
  • JANUVIA

    		•
    Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    Placebo,1 tablet per day for 12 months

    Outcome Measures

    Primary Outcome Measures

    1. Changes in late lumen loss of target lesion [Changes from baseline in late lumen loss of target lesion at 12 months]

      A coronary intermediate lesion in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with 3D QCA(3D Quantitative Coronary Angiography). To measure the changes in target lumen at 12 months.

    Secondary Outcome Measures

    1. Incidence rate of MACE [Incidence rate of MACE from baseline to 12 months]

      MACE include composite of death, myocardial infarction, or target-vessel revascularization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients > 18, < 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion.
    Exclusion Criteria:

    • Allergy or hypersensitivity to any of the drug's components.

    • Severe liver failure, moderate or severe kidney failure

    • Malignant disease.

    • Active infectious disease.

    • Pregnancy or breastfeeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The General Hospital of PLA Beijing Beijing China 100853

    Sponsors and Collaborators

    • Li Bo

    Investigators

    • Principal Investigator: Chen yundai, MD, The General Hospital of PLA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Li Bo, Director, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT02655757
    Other Study ID Numbers:
    • 301_xnk
    First Posted:
    Jan 14, 2016
    Last Update Posted:
    Jan 25, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Atherosclerosis
    Diabetes Mellitus, Type 2
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Jan 25, 2018