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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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. |
|
| Control group | Other | patients continue previously prescribed medication intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10Mg Tab | Drug | Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Barbarash | Research Institute for complex issues of cardiovascular diseases | Principal Investigator |
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|
| hypoglycemic therapy | Drug | hypoglycemic therapy. |
|
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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