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Clinical Trials in the EU / 2025-523977-40-00
Authorised Phase IV

Changes in Coronary Plaque Composition By Semaglutide Use in Diabetic Patients With Acute Coronary Syndrome: A Randomized Optical Coherence Tomography Trial - ARMYDA - 10 study

2025-523977-40-00 · tracked via the Priya Life Science EU tracker
Sponsor
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Cardiovascular Diseases
Decision date
28/01/2026
Enrollment target
90
Sites
Italy

Condition studied

non-ST-elevation myocardial infarction (NSTEMI); unstable angina, diabetes mellitus

Investigational medicinal product(s)

Rybelsus 3 mg tablets

Eligibility

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

Primary endpoint

the change of the maximum macrophage arc (degrees) in non-culprit coronary stenoses from baseline to 24 weeks, measured by OCT, in the semaglutide vs control arm

Endpoint detail

changes from baseline to 24 weeks in OCT parameters (lumen area, plaque volume, fibrous cap thickness, lipid/calcium arcs and lengths), plaque composition (fibrous, fibro-calcific, fibro-atheroma, TCFA), prevalence of healed and macrophage-rich plaques, HbA1c, BMI, and incidence of cardiovascular events and adverse effects.

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 2025-523977-40-00 on CTIS ↗ ← All trials in the EU