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Clinical Trials in the EU / 2025-523375-29-00
Authorised, recruiting Phase III

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

2025-523375-29-00 · tracked via the Priya Life Science EU tracker
Sponsor
Humanitas Mirasole S.p.A
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Cardiovascular Diseases
Decision date
06/02/2026
Enrollment target
300
Sites
Italy

Condition studied

diabetes mellitus, Myocardial Infarction

Investigational medicinal product(s)

Jardiance 10 mg film-coated tabletsForxiga 10 mg film-coated tabletsInvokana 100 mg film-coated tabletsInvokana 300 mg film-coated tabletsForxiga 5 mg film-coated tabletsJardiance 25 mg film-coated tablets

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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).

Endpoint detail

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.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523375-29-00 on CTIS ↗ ← All trials in the EU