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

Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Study ID
NCT04497792
Phase
PHASE4
Status
Completed

Conditions

  • Coronary Artery Disease
  • Diabetes Mellitus
  • Percutaneous Coronary Intervention

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10Mg Tab — DRUG
    Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
  • hypoglycemic therapy — DRUG
    hypoglycemic therapy.

Study Details

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

Key Dates

Start date
Nov 30, 2016
Status verified
Sep 2021
Primary completion
Nov 30, 2018
Completion
Nov 30, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Other: Control group
    patients continue previously prescribed medication intake

Primary Outcome Measure

glomerular filtration rate(GFR) [ Time Frame: baseline-24 weeks ]

Related Studies