Status:
UNKNOWN
Effects of SGLT2 Inhibitor in Diabetic Patients With Coronary Artery Disease
Lead Sponsor:
Sheba Medical Center
Conditions:
Coronary Disease With Diabetes Mellitus
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to explore the effect of newly added SGLT2I medication or placebo, to standard medication regimen in diabetic patients with documented stable coronary disease. Therefore, in t...
Detailed Description
Patients with ischemic heart disease and diabetes are at a particularly high risk for the recurrence of cardiovascular events, conversely, certain classes of oral anti-diabetic medications have been s...
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus on oral therapy
- Stable documented ischemic Heart disease (\> 60 days post AMI, CABG or PCI)
- Sub-optimal Hb A1c defined as ≥ 7%
- Age \> 21
- Life expectancy \>1 year
Exclusion
- Events of clinical hypoglycemia during the past 6 months
- Recent (\< 60 days) acute coronary syndrome (ACS) or Cerebrovascular accident
- Transient ischemic attack (TIA) within the past year.
- Significant renal impairment (eGFR \< 60 ml/min/1.73 m2)
- History of recurrent UTI \\ vaginitis
- Past bladder cancer (TCC or other)
- History of diabetic keto-acidosis
- Planned coronary intervention or planed surgical intervention (PCI or CABG)
- Unstable arrhythmias (i.e. rapid atrial fibrillation, symptomatic bradycardia, recurrent ventricular arrhythmia that are clinically significant, etc.)
- Known hypersensitivity to study drug
- Type I diabetes
- Current Hb A1c \>9%
- Current Insulin treatment
- Active treatment with SGLT2I medication
- Inability to comply with study protocol
- Active malignancy other than basal cell carcinoma (BCC)
- Clinically advanced congestive heart failure - NYHA class III-IV
- Severe left ventricular dysfunction (LVEF\<30%) with NYHA II or any NYHA class with documented recent heart failure decompensation (\<3 months)
- Severe stable cardiac angina CCS III - IV or Unstable angina
- Chronic inflammation (i.e. IBD, Lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection)
- Pregnancy, lactation or child-bearing potential
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03398577
Start Date
February 1 2018
End Date
December 31 2018
Last Update
January 17 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba Medical Center, Cardiac Rehabilitation Institute
Tel Litwinsky, Israel, 52621