Sodium-glucose cotransporter-2 inhibitors to stABiLizE coronary atherosclerosis pro-gression after acute Myocardial Infarction in women and men with diabetes mellitus

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523375-29-00

Enrollment

300

Registered

2026-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, diabetes mellitus

Brief summary

The primary endpoint will be the change in total coronary percentage atheroma volume (PAV) on native (untreated) segments assessed by coronary CT angiography (CCTA) from baseline to 12 months follow-up. Change in PAV is defined as the difference between PAV at baseline and PAV at 12 months follow-up (PAV change = baseline PAV - 12 months PAV).

Detailed description

The secondary endpoints will include: inflammatory biomarkers, biochemical markers of glycaemic control, features of high-risk plaque composition evaluated at CCTA, degree of neointimal hyper-plasia on treated coronary segments at CCTA, adherence to therapy.

Interventions

DRUGForxiga 5 mg film-coated tablets

DRUGForxiga 10 mg film-coated tablets

DRUGJardiance 25 mg film-coated tablets

DRUGInvokana 300 mg film-coated tablets

DRUGInvokana 100 mg film-coated tablets

DRUGJardiance 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the change in total coronary percentage atheroma volume (PAV) on native (untreated) segments assessed by coronary CT angiography (CCTA) from baseline to 12 months follow-up. Change in PAV is defined as the difference between PAV at baseline and PAV at 12 months follow-up (PAV change = baseline PAV - 12 months PAV).	—

Secondary

Measure	Time frame
The secondary endpoints will include: inflammatory biomarkers, biochemical markers of glycaemic control, features of high-risk plaque composition evaluated at CCTA, degree of neointimal hyper-plasia on treated coronary segments at CCTA, adherence to therapy.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 7, 2026