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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Diabetes Mellitus
• Interventions: Drug: Empagliflozin 10Mg Tab; Drug: hypoglycemic therapy

• Registration Number: NCT04497792
• Lead Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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

Study Timeline

• Study Start: 2016-11
• Primary Completion: 2018-11
• Study Completion: 2019-11
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Empagliflozin 10Mg Tab	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	hypoglycemic therapy	patients continue previously prescribed medication intake

Primary Outcome Measures

Name	Time	Method
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.