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Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions (SAFARY)

Primary Purpose

Coronary Artery Disease, Diabetes Mellitus, Percutaneous Coronary Intervention

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Empagliflozin 10Mg Tab
hypoglycemic therapy
Sponsored by
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring stable coronary artery disease, empagliflozin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • signed inform concent
  • stable coronary artery disease
  • planned percutaneous coronary intervention
  • diabetes mellitus

Exclusion Criteria:

  • previously performed coronary revascularization
  • glomerular filtration rate less than 45 ml/min
  • intolerance to empagliflozin
  • serum potassium more than 5/5 mmol/l
  • heart failure (NYHA III-IV)
  • congenital heart disease
  • acute coronary syndrome less than 3 months before enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Treatment group

    Control group

    Arm Description

    The treatment group are patients with stable coronary artery disease before planned percutaneous coronary intervention. All of them will receive empagliflozin additionally to previously taken hypoglycemic treatment.

    patients continue previously prescribed medication intake

    Outcomes

    Primary Outcome Measures

    glomerular filtration rate(GFR)
    The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
    HbA1C level
    The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2020
    Last Updated
    September 15, 2021
    Sponsor
    Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04497792
    Brief Title
    Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
    Acronym
    SAFARY
    Official Title
    A Long-term, Randomized Study to Evaluate the Effects of Empagliflozin in Combination With Standard Hypoglycemic Therapy on Early and Long-term Results of Planned Percutaneous Coronary Interventions in Patients With Type 2 Diabetes.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    November 2018 (Actual)
    Study Completion Date
    November 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Research Institute for Complex Problems of Cardiovascular Diseases, Russia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes
    Detailed Description
    Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy. Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Diabetes Mellitus, Percutaneous Coronary Intervention
    Keywords
    stable coronary artery disease, empagliflozin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    The treatment group are patients with stable coronary artery disease before planned percutaneous coronary intervention. All of them will receive empagliflozin additionally to previously taken hypoglycemic treatment.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    patients continue previously prescribed medication intake
    Intervention Type
    Drug
    Intervention Name(s)
    Empagliflozin 10Mg Tab
    Other Intervention Name(s)
    metformin
    Intervention Description
    Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
    Intervention Type
    Drug
    Intervention Name(s)
    hypoglycemic therapy
    Other Intervention Name(s)
    metformin
    Intervention Description
    hypoglycemic therapy.
    Primary Outcome Measure Information:
    Title
    glomerular filtration rate(GFR)
    Description
    The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
    Time Frame
    baseline-24 weeks
    Title
    HbA1C level
    Description
    The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
    Time Frame
    baseline-24 weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: signed inform concent stable coronary artery disease planned percutaneous coronary intervention diabetes mellitus Exclusion Criteria: previously performed coronary revascularization glomerular filtration rate less than 45 ml/min intolerance to empagliflozin serum potassium more than 5/5 mmol/l heart failure (NYHA III-IV) congenital heart disease acute coronary syndrome less than 3 months before enrollment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olga Barbarash
    Organizational Affiliation
    Research Institute for complex issues of cardiovascular diseases
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions

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