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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04497792

Acronym

SAFARY

Enrollment

Registered

2020-08-04

Start date

2016-11-30

Completion date

2019-11-30

Last updated

2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Diabetes Mellitus, Percutaneous Coronary Intervention

Keywords

stable coronary artery disease, empagliflozin

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

Interventions

DRUGEmpagliflozin 10Mg Tab

Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication

DRUGhypoglycemic therapy

hypoglycemic therapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
glomerular filtration rate(GFR)	baseline-24 weeks	The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
HbA1C level	baseline-24 weeks	The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026