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
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring stable coronary artery disease, empagliflozin
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
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
NCT ID
NCT04497792
First Posted
July 30, 2020
Last Updated
September 15, 2021
Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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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