Clinical trial NCT03208465: Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery Disease
Official title: Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery disease_ELITE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Coronary Disease
Keywords: Empagliflozin
Sitagliptin
Myocardial perfusion reserve
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent change in global myocardial perfusion reserve (MPR) index
timeFrame: 6 months
Secondary outcomes:
measure: Percent change in regional MPR index
timeFrame: 6 months
measure: Absolute change in regional MPR index
timeFrame: 6 months
measure: Absolute change in global MPR index
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Oh M, Choi JH, Kim SO, Lee PH, Ahn JM, Lee SW, Moon DH, Lee CW. Comparison of empagliflozin and sitagliptin therapy on myocardial perfusion reserve in diabetic patients with coronary artery disease. Nucl Med Commun. 2021 Sep 1;42(9):972-978. doi: 10.1097/MNM.0000000000001429.