A Phase 4 interventional study of Empagliflozin 10Mg Tab and hypoglycemic therapy in Coronary Artery Disease, Diabetes Mellitus and Percutaneous Coronary Intervention, sponsored by Research Institute for Complex Problems of Cardiovascular Diseases, Russia. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Research Institute for Complex Problems of Cardiovascular Diseases, Russia · Phase 4, Interventional, and Treatment
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
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
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 40 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Research Institute for Complex Problems of Cardiovascular Diseases, Russia is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 continue previously prescribed medication intake
Drug: hypoglycemic therapy
Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
Also known as: metformin
hypoglycemic therapy.
Also known as: metformin
glomerular filtration rate(GFR)
The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
Time frame: baseline-24 weeks
HbA1C level
The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
Time frame: baseline-24 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Research Institute for Complex Problems of Cardiovascular Diseases, Russia