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OpenTrials
Completed

NCT Number: NCT04497792

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 10Mg Tab

Drug

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

Other names: metformin

hypoglycemic therapy

Drug

hypoglycemic therapy.

Other names: metformin

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Other

Registry information

Official study 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.

Acronym: SAFARY

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 4, 2020
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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