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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Coronary Artery Disease, Diabetes Mellitus, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Empagliflozin 10Mg Tab
* Drug: hypoglycemic therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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. | Drug: Empagliflozin 10Mg Tab<br>* Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication<br>* Other names: metformin;|
| Other: Control group<br>patients continue previously prescribed medication intake | Drug: hypoglycemic therapy<br>* hypoglycemic therapy.<br>* Other names: metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stable coronary artery disease, empagliflozin