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Completed

NCT Number: NCT03208465

Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery Disease

This trial evaluates the effects of Empagliflozin versus Sitagliptin, in addition to standard of care, on global myocardial perfusion reserve using dynamic single-photon emission computed tomography (SPECT) images.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women at least 19 years of age
  • Type 2 diabetes mellitus
  • Stable coronary artery disease
  • Global myocardial perfusion reserve (MPR) index < 2.5
  • The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

  • Contraindications to empagliflozin, Sitagliptin
  • DPP4 inhibitors or Sodium-glucose cotransporter-2(SGLT2) inhibitors within the previous 4 weeks
  • Insulin requiring diabetes
  • Poor glucose control (HbA1C>10 %)
  • Acute coronary syndrome
  • Stent placement within the previous 6 months
  • Previous coronary artery bypass graft surgery within the previous 6 months
  • Planned revascularization within 6 months
  • Heart failure requiring loop diuretics
  • Severe left ventricular hypertrophy (left ventricular septal wall thickness > 13mm)
  • Significant renal disease manifested by creatinine clearance of < 30 ml/min)
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase or Aspartate Aminotransferase > 3 times upper limit of normal)
  • Radiopaque material implanted in the chest wall (metal, silicone, etc.)
  • Contraindication to adenosine stress test
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Patient's pregnant or breast-feeding or child-bearing potential
  • Expected life expectancy < 1 year
  • Unwillingness or inability to comply with the procedures described in this protocol

Treatment and study plan

Empagliflozin

Drug

In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.

Sitagliptin

Drug

In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.

Primary outcomes

  1. Percent change in global myocardial perfusion reserve (MPR) index

    Time frame: 6 months

    Percent change in global myocardial perfusion reserve (MPR) index defined as (global MPR index at 6 months - global MPR index at baseline)/(global MPR index at baseline)x100.

    MPR index=stress myocardial flow/rest myocardial flow

Secondary outcomes

  1. Percent change in regional MPR index

    Time frame: 6 months

    Percent change in regional MPR index defined as (regional MPR index at 6 months - regional MPR index at baseline)/(regional MPR index at baseline)x100.

  2. Absolute change in regional MPR index

    Time frame: 6 months

  3. Absolute change in global MPR index

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

CHEOL WHAN LEE, M.D., Ph.D

Other

Registry information

Official study title

Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery disease_ELITE Trial

Acronym: ELITE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2017
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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