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

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Diabetes Mellitus

Treatments: Drug: Empagliflozin 10Mg Tab; Drug: hypoglycemic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04497792

16_001

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Drug: Empagliflozin 10Mg Tab

Control group

Other group

Description:

patients continue previously prescribed medication intake

Treatment:

Drug: hypoglycemic therapy