Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000924459p
Ethics application status
Submitted, not yet approved
Date submitted
18/06/2025
Date registered
25/08/2025
Date last updated
25/08/2025
Date data sharing statement initially provided
25/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
EMPRESS Trial: Assessing the efficacy of EMPagliflozin in REducing Coronary Stent ReStenosis Rates in Type 2 Diabetes
Scientific title
EMPRESS Trial: Assessing the efficacy of EMPagliflozin in REducing Coronary Stent ReStenosis Rates in Type 2 Diabetes
Secondary ID [1] 314684 0
None
Universal Trial Number (UTN)
Trial acronym
EMPRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 337854 0
Ischaemic Heart Disease 337855 0
Condition category
Condition code
Cardiovascular 334185 334185 0 0
Coronary heart disease
Metabolic and Endocrine 334186 334186 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Empagliflozin orally at 10mg daily for nine months.
Empagliflozin is to be commenced within 7 days of coronary stent procedure (as diabetic medications should be witheld peri-operatively)
Adherence will be assessed through laboratory test (HbA1c) and interview.
Intervention code [1] 331294 0
Treatment: Drugs
Comparator / control treatment
Other non-SGLT2 (sodium-glucose cotransporter 2) inhibitor medication for diabetes as per standard of care for nine months. This could be;
- Sulphonylurea such as gliclazide 30mg (modified release) oral tablet daily
- Glucagon-like peptide-1 receptor agonist (GLP-1RA) such as as semaglutide 0.25mg subcutaneous injection weekly
- Dipeptidyl peptidase 4 (DPP-4) Inhibitor such as sitagliptin 100mg oral tablet daily

Comparator medications will be commenced within one week of coronary stenting procedure (as diabetic medications should be witheld peri-operatively)
Control group
Active

Outcomes
Primary outcome [1] 341839 0
Late lumen loss defined as [(mean stented area - mean luminal area)/mean stented area]
Timepoint [1] 341839 0
Nine months following index coronary stenting procedure
Secondary outcome [1] 448802 0
Maximum lipid arc
Timepoint [1] 448802 0
Nine months following index coronary stenting procedure
Secondary outcome [2] 448803 0
Minimum fibrous cap thickness change
Timepoint [2] 448803 0
Nine months following index coronary stenting procedure
Secondary outcome [3] 448804 0
Lipid plaque length change (FCT < 120 µm and lipid arc > 90 degrees in at least 3 consecutive images)
Timepoint [3] 448804 0
Nine months following index coronary stenting procedure
Secondary outcome [4] 448805 0
Macrophage index
Timepoint [4] 448805 0
Nine months following index coronary stenting procedure
Secondary outcome [5] 448806 0
Strut coverage
Timepoint [5] 448806 0
Nine months following index coronary stenting procedure
Secondary outcome [6] 448807 0
Clinical biomarkers (composite outcome) • HbA1c • Lipid profile including LDL-Cholesterol, HDL and triglyceride • Full blood examination • Urea, electrolytes and creatinine.
Timepoint [6] 448807 0
At 3, 6 and 9 months following index coronary stenting procedure
Secondary outcome [7] 448808 0
Major adverse cardiovascular events (composite of death, myocardial infarction, target vessel revascularisation and hospitalisation)
Timepoint [7] 448808 0
Nine months following index coronary stenting procedure
Secondary outcome [8] 448809 0
Blood pressure
Timepoint [8] 448809 0
Nine months following index coronary stenting procedure

Eligibility
Key inclusion criteria
• Stable angina or non-culprit lesions in acute coronary syndrome
• Planned for coronary stenting with a drug-eluting stent (everolimus-based) with distal reference vessel of at least 2.5 mm and estimated length of at most 48 mm
• Diabetes on metformin without pre-treatment of SGLT2i
• HbA1c below 10%
• Adults (above 18 years old) who can provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Culprit lesions in acute coronary syndrome
• Patient with left main coronary artery stenosis
• Patients with cardiogenic shock
• Distal reference vessel < 2.5 mm
• History of severe urosepsis
• Concurrent pregnancy
• eGFR < 45 ml/min

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANCOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/10/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2027
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28119 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 44323 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 319232 0
Government body
Name [1] 319232 0
Royal Australasian College of Physicians
Country [1] 319232 0
Australia
Funding source category [2] 319233 0
Government body
Name [2] 319233 0
Diabetes Australia
Country [2] 319233 0
Australia
Funding source category [3] 319234 0
Government body
Name [3] 319234 0
Northern Health
Country [3] 319234 0
Australia
Funding source category [4] 319235 0
Commercial sector/Industry
Name [4] 319235 0
Abbott Cardiovascular
Country [4] 319235 0
Australia
Primary sponsor type
Government body
Name
Northern Health
Address
Country
Australia
Secondary sponsor category [1] 321703 0
None
Name [1] 321703 0
None
Address [1] 321703 0
Country [1] 321703 0
Other collaborator category [1] 283551 0
University
Name [1] 283551 0
Monash University
Address [1] 283551 0
Country [1] 283551 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317812 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317812 0
Ethics committee country [1] 317812 0
Australia
Date submitted for ethics approval [1] 317812 0
21/05/2025
Approval date [1] 317812 0
Ethics approval number [1] 317812 0
Monash Health Local Reference: RES-25-0000-202A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142238 0
Dr Hashrul Rashid
Address 142238 0
Melbourne Heart Care, Suite 16, 3 Male Street, Brighton, 3186 VIC
Country 142238 0
Australia
Phone 142238 0
+61 420276756
Fax 142238 0
Email 142238 0
[email protected]
Contact person for public queries
Name 142239 0
Hashrul Rashid
Address 142239 0
Melbourne Heart Care, Suite 16, 3 Male Street, Brighton, 3186 VIC
Country 142239 0
Australia
Phone 142239 0
+61 395922177
Fax 142239 0
Email 142239 0
[email protected]
Contact person for scientific queries
Name 142240 0
Hashrul Rashid
Address 142240 0
Melbourne Heart Care, Suite 16, 3 Male Street, Brighton, 3186 VIC
Country 142240 0
Australia
Phone 142240 0
+61 395922177
Fax 142240 0
Email 142240 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.