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

Coronary Artery Disease Clinical Trial

— SAFARY  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497792
• Other study ID #: 16_001
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: November 2019

Study information

• Verified date: September 2021
• Source: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Drug:
• Empagliflozin 10Mg Tab
Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
• hypoglycemic therapy
hypoglycemic therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	HbA1C level	The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.	baseline-24 weeks