Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
SAFARY
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.
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
Started Nov 2016
Typical duration for phase_4 coronary-artery-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedSeptember 22, 2021
September 1, 2021
2 years
July 30, 2020
September 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
glomerular filtration rate(GFR)
The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
baseline-24 weeks
HbA1C level
The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
baseline-24 weeks
Study Arms (2)
Treatment group
EXPERIMENTALThe 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.
Control group
OTHERpatients continue previously prescribed medication intake
Interventions
Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
Eligibility Criteria
You may qualify if:
- signed inform concent
- stable coronary artery disease
- planned percutaneous coronary intervention
- diabetes mellitus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olga Barbarash
Research Institute for complex issues of cardiovascular diseases
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal
Study Record Dates
First Submitted
July 30, 2020
First Posted
August 4, 2020
Study Start
November 1, 2016
Primary Completion
November 1, 2018
Study Completion
November 1, 2019
Last Updated
September 22, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share