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

• Sponsor: CHEOL WHAN LEE, M.D., Ph.D (Other)
• Overall Status: Completed
• CT.gov ID: NCT03208465
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.8
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual 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: Aug 7, 2017
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percent change in global myocardial perfusion reserve (MPR) index [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 [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 [6 months]

3. Absolute change in global MPR index [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• CHEOL WHAN LEE, M.D., Ph.D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHEOL WHAN LEE, M.D., Ph.D, professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03208465
• Other Study ID Numbers: AMCCV2016-20
• First Posted: Jul 5, 2017
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, professor, Asan Medical Center: Empagliflozin; Sitagliptin; Myocardial perfusion reserve
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Sitagliptin Phosphate; Empagliflozin

Study Results

No Results Posted as of Aug 7, 2019