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

September 15, 2021 updated by: Olga Barbarash, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Empagliflozin 10Mg Tab
Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
Other Names:
  • metformin
Other: Control group
patients continue previously prescribed medication intake
Drug: hypoglycemic therapy
hypoglycemic therapy.
Other Names:
  • metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glomerular filtration rate(GFR)
Time Frame: baseline-24 weeks
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
Time Frame: baseline-24 weeks
The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
baseline-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Investigators

  • Principal Investigator: Olga Barbarash, Research Institute for Complex Issues of Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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