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Effects of SGLT2 Inhibitor in Diabetic Patients With Coronary Artery Disease

NCT03398577 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-01-17

No results posted yet for this study

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 the present study the investigators plan to focus on possible anti-inflammatory and athero-thrombotic protective effects of Dapagliflozin compared to placebo, in secondary prevention population of stable coronary patients with diabetes. Additionally, the investigators will explore NT proBNP dynamics, which related to ventricular filling pressures in this specific population.

Conditions

  • Coronary Disease With Diabetes Mellitus

Interventions

DRUG

Dapagliflozin 10 MG [Farxiga]

Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.

DRUG

Placebo Oral Tablet

Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Robert Klempfner, Proffesor · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-08-31
Completion
2018-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398577 on ClinicalTrials.gov