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

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ClinicalTrials.gov Identifier: NCT03208465
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Coronary Disease Drug: Empagliflozin Drug: Sitagliptin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery disease_ELITE Trial
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with Empagliflozin Drug: Empagliflozin
In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.

Active Comparator: Patients with Sitagliptin Drug: Sitagliptin
In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208465


Contacts
Contact: Cheol-whan Lee, MD 82230103150 cheolwlee@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Cheol-whan Lee, MD    +82230103150    cheolwlee@amc.seoul.kr   
Principal Investigator: Cheol-Whan Lee, MD         
Sponsors and Collaborators
CHEOL WHAN LEE, M.D., Ph.D

Responsible Party: CHEOL WHAN LEE, M.D., Ph.D, professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03208465     History of Changes
Other Study ID Numbers: AMCCV2016-20
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center:
Empagliflozin
Sitagliptin
Myocardial perfusion reserve

Additional relevant MeSH terms:
Empagliflozin
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action