Early use of dapagliflozin in patients with acute myocardial infarction and reduced ejection fraction: the randomized ARMYDA-9 Dapagliflozin trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-08-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The aim will be to study the potential cardioprotective effects (primarily the reduction of the infarct size) of an early use of the SGLT-2 inhibitor, to evaluate its safety (occurrence of a composite event including cardiovascular death, worsening of heart failure during hospitalization, myocardial re-infarction, stroke, or unplanned coronary revascularization) and side effects

Conditions and MedDRA coding

Acute Myocardial Infarction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥18 years
2. STEMI regardless of the involved epicardial territories
3. Primary PCI <12 hours from symptom onset
4. TIMI coronary flow 0-1 at the time of primary PCI
5. Imaging evidence of new regional wall motion abnormality and LVEF ≤40% by ventriculography performed at the time of primary PCI or by trans-thoracic echocardiography performed as soon as possible within 12 hours from admission
6. Written informed consent to participate the study

Exclusion criteria 11

1. Cardiogenic shock on admission
2. Symptomatic hypotension or blood pressure <90 mmHg
3. History of restrictive cardiomyopathy, constrictive pericarditis, hypertrophic cardiomyopathy or untreated severe heart valve disease
4. History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes
5. History of heart failure with NYHA IV
6. Severe hepatic insufficiency
7. Active cancer
8. eGFR<30 ml/min
9. Hypersensitivity to the active substance or to any of the excipients
10. Pregnancy or breastfeeding. For women of childbearing potential, any pregnancy status must be ascertained with a pregnancy test during the screening or randomization visit
11. Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or in the 5 half-lives of the study drug, whichever is longer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoint will be the infarct size, as assessed by cardiac MRI performed at 3-month follow-up, in the two arms. The adjudication of the primary outcome will be performed by a centralized, completely blinded analysis. Infarct size will be measured as percentage of left ventricular mass. Gadobutrol at the dose of 0.15 mmol/Kg will be used as contrast agent, with late gadolinium enhancement starting at 15 min onward. 5-SD will be utilized as method for quantification of infarct size.

Secondary endpoints 3

1. Clinical secondary outcomes: Time to occurrence of the composite outcome measure including cardiovascular death, worsening HF during index hospitalization or post-discharge HF requiring repeat hospitalization within 3 months. Occurrence of re-MI, stroke or unplanned coronary revascularization at 3 months. All-cause death at 3 months. Duration of in-hospital stay for the index event. Difference in the change of body weight from randomization to 3-month follow-up. Arterial pressure values during h
2. Imaging secondary outcomes: Cardiac MRI, Transthoracic echocardiography
3. Laboratory secondary outcomes: B-type natriuretic peptide, Renal function, EPO, Red blood cell

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Sponsor organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Address

Corso Giuseppe Mazzini 18

City

Novara

Postcode

28100

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Contact name

Clinical Trial Center

Public contact point

Organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Contact name

Clinical Trial Center

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications