- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497792
Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions (SAFARY)
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.
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
Other Names:
|
Other: Control group
patients continue previously prescribed medication intake
|
hypoglycemic therapy.
Other Names:
|
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
Investigators
- Principal Investigator: Olga Barbarash, Research Institute for Complex Issues of Cardiovascular Diseases
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Diabetes Mellitus
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- Hypoglycemic Agents
- Metformin
- Empagliflozin
Other Study ID Numbers
- 16_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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