Clinical trial • Phase III • Cardiology | Endocrinology
CANAGLIFLOZIN for Acute myocardial infarction | Diabetes mellitus
Phase III trial of CANAGLIFLOZIN for Acute myocardial infarction | Diabetes mellitus. 300 participants.
Overview
- Trial Therapeutic Area
- Cardiology | Endocrinology
- Trial Disease
- Acute myocardial infarction | Diabetes mellitus
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-10-2025
- First CTIS Authorization Date
- 06-02-2026
Trial design
Phase III trial across 9 sites in Italy.
- Target Sample Size
- 300
- Trial Duration For Participant
- 365
Eligibility
Recruits 300 Vulnerable population not selected. Participants must be able to provide informed consent (inclusion criterion: "Ability to provide informed consent"). Subject information and informed consent forms for adults are provided; no provisions for assent or enrolment of minors are indicated..
- Pregnancy Exclusion
- Known pregnancy
- Vulnerable Population
- Vulnerable population not selected. Participants must be able to provide informed consent (inclusion criterion: "Ability to provide informed consent"). Subject information and informed consent forms for adults are provided; no provisions for assent or enrolment of minors are indicated.
Inclusion criteria
- {"criterion_text":"- Age ≥18 years\n- Established diagnosis of non-insulin-dependent diabetes mellitus\n- Hospital admission for AMI (with or without ST-segment elevation); AMI diagnosis should be confirmed with a troponin measurement according to the Fourth Universal Definition of Myocardial Infarction\n- Successful PCI\n- Complete revascularization obtained within the index hospitalization\n- Ability to provide informed consent"}
Exclusion criteria
- {"criterion_text":"- Known intolerance/contraindications to SGLT2i therapy\n- Ongoing treatment with SGLT2i at the time of AMI\n- Contraindications to undergo CCTA\n- Insulin-dependent diabetes mellitus\n- Incomplete revascularization with indication to staged PCI on non-culprit lesions\n- Left ventricular ejection fraction <35% prior to discharge\n- Known allergy to aspirin or ticagrelor\n- Known pregnancy\n- Life expectancy <1 year for non-cardiac conditions"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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).","definition_or_measurement_approach":"PAV assessed by coronary CT angiography (CCTA) at baseline and at 12 months; primary endpoint is the change in total coronary percentage atheroma volume (PAV) defined as baseline PAV - 12 months PAV."}
Secondary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Includes measurement of inflammatory biomarkers and biochemical markers of glycaemic control (laboratory assays), evaluation of high-risk plaque composition and degree of neointimal hyperplasia by CCTA, and assessment of adherence to therapy. Specific measurement methods referenced in endpoint description (e.g., CCTA for plaque and neointimal hyperplasia)."}
Recruitment
- Planned Sample Size
- 300
- Recruitment Window Months
- 32
- Consent Approach
- Informed consent must be provided by participants (inclusion criterion: "Ability to provide informed consent"). Subject information and informed consent forms for adults are available (multiple L1 / L2 ICF documents listed). No assent procedures or paediatric consent documents referenced. Documents appear to be available in Italian.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 300
Italy
- Earliest CTIS Part Ii Submission Date
- 09-10-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 158
- Number Of Sites
- 9
- Number Of Participants
- 300
Sites
- Site Name
- Ospedale Galeazzi S.p.A.
- Department Name
- Division of University Cardiology
- Principal Investigator Name
- Daniele Andreini
- Principal Investigator Email
- daniele.andreini@unimi.it
- Contact Person Name
- Daniele Andreini
- Contact Person Email
- daniele.andreini@unimi.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Cardiovascular Department
- Principal Investigator Name
- Giulio Stefanini
- Principal Investigator Email
- giulio.stefanini@hunimed.eu
- Contact Person Name
- Giulio Stefanini
- Contact Person Email
- giulio.stefanini@hunimed.eu
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- System Medicine Department
- Principal Investigator Name
- Massimo Federici
- Principal Investigator Email
- federicicm@uniroma2.it
- Contact Person Name
- Massimo Federici
- Contact Person Email
- federicicm@uniroma2.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Cardiovascular and Toracic Department
- Principal Investigator Name
- Fabrizio D'Ascenzo
- Principal Investigator Email
- fabrizio.dascenzo@gmail.com
- Contact Person Name
- Fabrizio D'Ascenzo
- Contact Person Email
- fabrizio.dascenzo@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- Division of Cardiology
- Principal Investigator Name
- Emanuele Barbato
- Principal Investigator Email
- emanuele.barbato@uniroma1.it
- Contact Person Name
- Emanuele Barbato
- Contact Person Email
- emanuele.barbato@uniroma1.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Geriatrics and Internal Medicine
- Principal Investigator Name
- Giuseppe Paolisso
- Principal Investigator Email
- giuseppe.paolisso@unicampania.it
- Contact Person Name
- Giuseppe Paolisso
- Contact Person Email
- giuseppe.paolisso@unicampania.it
- Site Name
- Azienda Ospedaliera Regionale San Carlo
- Department Name
- Cardiology
- Principal Investigator Name
- Eugenio Stabile
- Principal Investigator Email
- eugenio.stabile@ospedalesancarlo.it
- Contact Person Name
- Eugenio Stabile
- Contact Person Email
- eugenio.stabile@ospedalesancarlo.it
- Site Name
- Ospedale Santa Maria Goretti Latina
- Department Name
- UOC UTIC Cardiology
- Principal Investigator Name
- Francesco Versaci
- Principal Investigator Email
- f.versaci@ausl.latina.it
- Contact Person Name
- Francesco Versaci
- Contact Person Email
- f.versaci@ausl.latina.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Pathology Department; Cardiothoracic Department
- Principal Investigator Name
- Rosalinda Madonna
- Principal Investigator Email
- rosalinda.madonna@unipi.it
- Contact Person Name
- Rosalinda Madonna
- Contact Person Email
- rosalinda.madonna@unipi.it
Sponsor
Primary sponsor
- Full Name
- Humanitas Mirasole S.p.A.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- Invokana 300 mg film-coated tablets
- Active Substance
- CANAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 300 mg
- Maximum Dose
- 300 mg
- Investigational Product Name
- Jardiance 25 mg film-coated tablets
- Active Substance
- EMPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 25 mg
- Maximum Dose
- 25 mg
- Investigational Product Name
- Invokana 100 mg film-coated tablets
- Active Substance
- CANAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg
- Maximum Dose
- 100 mg
- Investigational Product Name
- Forxiga 10 mg film-coated tablets
- Active Substance
- DAPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 10 mg
- Maximum Dose
- 10 mg
- Investigational Product Name
- Jardiance 10 mg film-coated tablets
- Active Substance
- EMPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 10 mg
- Maximum Dose
- 10 mg
- Investigational Product Name
- Forxiga 5 mg film-coated tablets
- Active Substance
- DAPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 5 mg
- Maximum Dose
- 5 mg
- Combination Treatment
- Yes
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