<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497792</url>
  </required_header>
  <id_info>
    <org_study_id>16_001</org_study_id>
    <nct_id>NCT04497792</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions</brief_title>
  <acronym>SAFARY</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Institute for Complex Problems of Cardiovascular Diseases, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Research Institute for Complex Problems of Cardiovascular Diseases, Russia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation&#xD;
      tool, as well as to improve the long-term prognosis of planned percutaneous coronary&#xD;
      interventions in patients with type 2 diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One&#xD;
      group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary&#xD;
      interventions and for 12 months thereafter in addition to previously taken hypoglycemic&#xD;
      therapy. Patients of the second group will continue to take previously prescribed&#xD;
      hypoglycemic therapy.&#xD;
&#xD;
      Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients&#xD;
      with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as&#xD;
      well as the impact on the immediate and long-term outcomes of percutaneous coronary&#xD;
      interventions in comparison with patients on standard hypoglycemic therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>glomerular filtration rate(GFR)</measure>
    <time_frame>baseline-24 weeks</time_frame>
    <description>The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HbA1C level</measure>
    <time_frame>baseline-24 weeks</time_frame>
    <description>The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients continue previously prescribed medication intake</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin 10Mg Tab</intervention_name>
    <description>Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>metformin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hypoglycemic therapy</intervention_name>
    <description>hypoglycemic therapy.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>metformin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed inform concent&#xD;
&#xD;
          -  stable coronary artery disease&#xD;
&#xD;
          -  planned percutaneous coronary intervention&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previously performed coronary revascularization&#xD;
&#xD;
          -  glomerular filtration rate less than 45 ml/min&#xD;
&#xD;
          -  intolerance to empagliflozin&#xD;
&#xD;
          -  serum potassium more than 5/5 mmol/l&#xD;
&#xD;
          -  heart failure (NYHA III-IV)&#xD;
&#xD;
          -  congenital heart disease&#xD;
&#xD;
          -  acute coronary syndrome less than 3 months before enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Barbarash</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute for complex issues of cardiovascular diseases</affiliation>
  </overall_official>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>September 15, 2021</last_update_submitted>
  <last_update_submitted_qc>September 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Research Institute for Complex Problems of Cardiovascular Diseases, Russia</investigator_affiliation>
    <investigator_full_name>Olga Barbarash</investigator_full_name>
    <investigator_title>Principal</investigator_title>
  </responsible_party>
  <keyword>stable coronary artery disease</keyword>
  <keyword>empagliflozin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Empagliflozin</mesh_term>
    <mesh_term>Hypoglycemic Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497792
org study id: 16_001
nct id: NCT04497792
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: glomerular filtration rate(GFR)
time frame: baseline-24 weeks
description: The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
measure: HbA1C level
time frame: baseline-24 weeks
description: The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
arm group label: Treatment group
arm group type: Experimental
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 group label: Control group
arm group type: Other
description: patients continue previously prescribed medication intake
intervention type: Drug
intervention name: Empagliflozin 10Mg Tab
description: Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
arm group label: Treatment group
other name: metformin
intervention type: Drug
intervention name: hypoglycemic therapy
description: hypoglycemic therapy.
arm group label: Control group
other name: metformin
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Olga Barbarash
role: Principal Investigator
affiliation: Research Institute for complex issues of cardiovascular diseases
responsible party type: Principal Investigator
investigator affiliation: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
investigator full name: Olga Barbarash
investigator title: Principal
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Diabetes Mellitus
mesh term: Metformin
mesh term: Empagliflozin
mesh term: Hypoglycemic Agents
sharing ipd: No