Status:
COMPLETED
Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
Lead Sponsor:
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Conditions:
Coronary Artery Disease
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- signed inform concent
- stable coronary artery disease
- planned percutaneous coronary intervention
- diabetes mellitus
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04497792
Start Date
November 1 2016
End Date
November 1 2019
Last Update
September 22 2021
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