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

NCT ID: NCT04497792

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-11-30

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

Conditions

Coronary Artery Disease; Diabetes Mellitus; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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.

Group Type: EXPERIMENTAL

Empagliflozin 10Mg Tab

Intervention Type: DRUG

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

Control group

patients continue previously prescribed medication intake

Group Type: OTHER

hypoglycemic therapy

Intervention Type: DRUG

hypoglycemic therapy.

Interventions

Empagliflozin 10Mg Tab

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

Intervention Type: DRUG

hypoglycemic therapy

hypoglycemic therapy.

Intervention Type: DRUG

Other Intervention Names

metformin; metformin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

OTHER

Sponsor Role: lead

Responsible Party

Olga Barbarash

Principal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Barbarash

Role: PRINCIPAL_INVESTIGATOR

Research Institute for complex issues of cardiovascular diseases

Other Identifiers

16_001

Identifier Type: -

Identifier Source: org_study_id