Clinical trial • Phase III • Cardiology
COLCHICINE for Heart failure | Ischemic heart disease
Phase III trial of COLCHICINE for Heart failure | Ischemic heart disease.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Heart failure | Ischemic heart disease
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-07-2024
- First CTIS Authorization Date
- 30-10-2024
Trial design
Randomised, open-label, colchicine versus placebo: colchicina lirca 0.5 mg compresse (colchicine; max daily dose 0.5 mg) compared to placebo tablet matching colchicina. thiamine versus control: benerva 300 mg compresse gastroresistenti (thiamine hydrochloride; max daily dose 300 mg) compared to no thiamine (control). Phase III trial across 19 sites in Italy.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Colchicine versus placebo: COLCHICINA LIRCA 0.5 mg compresse (colchicine; max daily dose 0.5 mg) compared to Placebo tablet matching Colchicina. Thiamine versus control: Benerva 300 mg compresse gastroresistenti (thiamine hydrochloride; max daily dose 300 mg) compared to no thiamine (control).
- Target Sample Size
- 2200
Eligibility
Recruits 2200 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (minimum age 45). Informed consent documents are available (e.g. L1_ICF_Consent_Form_IT_public and site-specific variants). Consent is obtained from participants..
- Pregnancy Exclusion
- Female who is pregnant, breast-feeding or is considering becoming pregnant during the study
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (minimum age 45). Informed consent documents are available (e.g. L1_ICF_Consent_Form_IT_public and site-specific variants). Consent is obtained from participants.
Inclusion criteria
- {"criterion_text":"- Age greater than or equal to 45 years\n- Documented ischemic heart disease as the etiology of HF, which includes: a) a history of CAD, and b) determination of the cause of HF to be due to IHD based on local investigator assessment\n- NYHA class II-IV symptoms\n- Documented LVEF less than or equal to 45% within 1 year prior to enrollment\n- Optimal medical treatment for HF as per local clinical practice\n- Participants can be enrolled in the ambulatory or hospitalized setting"}
Exclusion criteria
- {"criterion_text":"- Female who is pregnant, breast-feeding or is considering becoming pregnant during the study\n- Concurrent use of other experimental pharmacologic agents\n- Regular or required use colchicine or thiamine for other clinical indications\n- History of allergic reaction to colchicine or to thiamine; or current or planned use of cyclosporine, verapamil, diltiazem, azole antifungal, macrolide antibiotic (except azithromycin), or HIV protease inhibitor\n- Use of a ventricular assist device or prior heart transplant\n- Severe valvular disease\n- Coronary revascularization (coronary artery bypass graft surgery or percutaneous coronary intervention) within the 4 weeks prior to enrollment, or planned within the next 4 weeks.\n- Chronic and severe renal dysfunction defined as eGFR < 15 mL/min/1.73m2 based on local laboratory measurement done within 6 months prior to run-in\n- History of liver cirrhosis\n- Active malignancy (excluding basal cell or treated squamous cell carcinoma of the skin) requiring treatment and with a life-expectancy of <2 years."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Colchicine arm: Composite of CV death, HF event, or ischemic CV event (defined as myocardial infarction, ischemic stroke, or arterial revascularization)","definition_or_measurement_approach":"Composite defined as CV death, HF event, or ischemic cardiovascular events (myocardial infarction, ischemic stroke, or arterial revascularization) as stated."}
- {"endpoint_text":"- Thiamine arm: Composite of CV death or HF event","definition_or_measurement_approach":"Composite of CV death or HF event as stated."}
Secondary endpoints
- {"endpoint_text":"- All cause death, hospitalization","definition_or_measurement_approach":""}
- {"endpoint_text":"- Serious adverse events","definition_or_measurement_approach":""}
- {"endpoint_text":"- Side effects or adverse events resulting in study drug discontinuation","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 2200
- Recruitment Window Months
- 43
- Consent Approach
- Informed consent obtained from adult participants. Consent documents available for publication (e.g. L1_ICF_Consent_Form_IT_public and site-specific L1_ICF_Consent_Form_IT_Niguarda_public). Documents indicate Italian-language materials (suffix _IT). No assent/minor consent procedures are indicated (minimum age 45).
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 2200
Italy
- Earliest CTIS Part Ii Submission Date
- 27-09-2024
- Latest Decision Or Authorization Date
- 04-08-2025
- Processing Time Days
- 311
- Number Of Sites
- 19
- Number Of Participants
- 300
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Della Valle Olona
- Department Name
- U.O.C. DI CARDIOLOGIA
- Principal Investigator Name
- Daniele Nassiacos
- Principal Investigator Email
- daniele.nassiacos@asst-valleolona.it
- Contact Person Name
- Daniele Nassiacos
- Contact Person Email
- daniele.nassiacos@asst-valleolona.it
- Site Name
- Alessandro Manzoni Hospital
- Department Name
- S.C. DI CARDIOLOGIA
- Principal Investigator Name
- Giuseppe Uccello
- Principal Investigator Email
- giuseppe.uccello@yahoo.it
- Contact Person Name
- Giuseppe Uccello
- Contact Person Email
- giuseppe.uccello@yahoo.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- UOC CARDIOLOGIA
- Principal Investigator Name
- Domenico Gabrielli
- Principal Investigator Email
- dgabrielli@scamilloforlanini.rm.it
- Contact Person Name
- Domenico Gabrielli
- Contact Person Email
- dgabrielli@scamilloforlanini.rm.it
- Site Name
- Policlinico San Donato S.p.A.
- Department Name
- CARDIOLOGIA RIABILITATIVA
- Principal Investigator Name
- Massimo Piepoli
- Principal Investigator Email
- massimo.piepoli@unimi.it
- Contact Person Name
- Massimo Piepoli
- Contact Person Email
- massimo.piepoli@unimi.it
- Site Name
- Azienda Unita Sanitaria Locale Umbria 1
- Department Name
- U.O. DI UTIC E CARDIOLOGIA
- Principal Investigator Name
- Euro Antonio Capponi
- Principal Investigator Email
- euro.capponi@uslumbria1.it
- Contact Person Name
- Euro Antonio Capponi
- Contact Person Email
- euro.capponi@uslumbria1.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O. CARDIOLOGIA
- Principal Investigator Name
- Filippo Ottani
- Principal Investigator Email
- ottanif@alice.it
- Contact Person Name
- Filippo Ottani
- Contact Person Email
- ottanif@alice.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD CARDIOLOGIA OSPEDALIERA E UTIC
- Principal Investigator Name
- Marco Marini
- Principal Investigator Email
- marcomarini1975@gmail.com
- Contact Person Name
- Marco Marini
- Contact Person Email
- marcomarini1975@gmail.com
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- SC CARDIOLOGIA 1
- Principal Investigator Name
- Emilia D'Elia
- Principal Investigator Email
- edelia@asst-pg23.it
- Contact Person Name
- Emilia D'Elia
- Contact Person Email
- edelia@asst-pg23.it
- Site Name
- Azienda Sanitaria Locale Della Provincia Di Bari
- Department Name
- CARDIOLOGIA-UTIC
- Principal Investigator Name
- Luisa De Gennaro
- Principal Investigator Email
- luisadegennaro@hotmail.com
- Contact Person Name
- Luisa De Gennaro
- Contact Person Email
- luisadegennaro@hotmail.com
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Cardiologia 2 - insufficienza cardiaca e trapianto
- Principal Investigator Name
- Iside Maria Cartella
- Principal Investigator Email
- iside.cartella@ospedaleniguarda.it
- Contact Person Name
- Iside Maria Cartella
- Contact Person Email
- iside.cartella@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- S.C. DI CARDIOLOGIA UNIVERSITARIA-UTIC
- Principal Investigator Name
- Michele Correale
- Principal Investigator Email
- michele.correale@libero.it
- Contact Person Name
- Michele Correale
- Contact Person Email
- michele.correale@libero.it
- Site Name
- Azienda Ospedaliera Per L'Emergenza Cannizzaro
- Department Name
- UOC CARDIOLOGIA
- Principal Investigator Name
- Francesco Amico
- Principal Investigator Email
- famico64@gmail.com
- Contact Person Name
- Francesco Amico
- Contact Person Email
- famico64@gmail.com
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- SOC CARDIOLOGIA OSPEDALIERA
- Principal Investigator Name
- Alessandro Navazio
- Principal Investigator Email
- alessandro.navazio@ausl.re.it
- Contact Person Name
- Alessandro Navazio
- Contact Person Email
- alessandro.navazio@ausl.re.it
- Site Name
- Azienda Ospedaliera S Giovanni Addolorata
- Department Name
- UOC CARDIOLOGIA D'URGENZA E UTIC
- Principal Investigator Name
- Vittoria Rizzello
- Principal Investigator Email
- vrizzello@hsangiovanni.roma.it
- Contact Person Name
- Vittoria Rizzello
- Contact Person Email
- vrizzello@hsangiovanni.roma.it
- Site Name
- ARNAS Civico Di Cristina Benfratelli
- Department Name
- UOSD CARDIOLOGIA CLINICA TRATTAM. SCOMPENSO CARD.
- Principal Investigator Name
- Egle Incalcaterra
- Principal Investigator Email
- egle.incalcaterra@gmail.com
- Contact Person Name
- Egle Incalcaterra
- Contact Person Email
- egle.incalcaterra@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- CARDIOLOGIA UTIC
- Principal Investigator Name
- Giuseppe Leonardi
- Principal Investigator Email
- leonardi.pippo@gmail.com
- Contact Person Name
- Giuseppe Leonardi
- Contact Person Email
- leonardi.pippo@gmail.com
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O. DI CARDIOLOGIA-UTIC
- Principal Investigator Name
- Michela Bartolotti
- Principal Investigator Email
- michela.bartolotti@auslromagna.it
- Contact Person Name
- Michela Bartolotti
- Contact Person Email
- michela.bartolotti@auslromagna.it
- Site Name
- Azienda Sanitaria Locale Roma 1
- Department Name
- CARDIOLOGIA CLINICA E RIABILITATIVA
- Principal Investigator Name
- Furio Colivicchi
- Principal Investigator Email
- furio.colivicchi@aslroma1.it
- Contact Person Name
- Furio Colivicchi
- Contact Person Email
- furio.colivicchi@aslroma1.it
- Site Name
- Azienda Sanitaria Locale Roma 2
- Department Name
- UOC CARDIOLOGIA - UTIC
- Principal Investigator Name
- Claudia Chialastri
- Principal Investigator Email
- claudia.chialastri@aslroma2.it
- Contact Person Name
- Claudia Chialastri
- Contact Person Email
- claudia.chialastri@aslroma2.it
Sponsor
Primary sponsor
- Full Name
- Hamilton Health Sciences Corporation
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Canada
Investigational products
- Investigational Product Name
- COLCHICINA LIRCA 0.5 mg compresse
- Active Substance
- COLCHICINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation in IT: marketingAuthNumber 009964040)
- Starting Dose
- 0.5 mg
- Maximum Dose
- 0.5 mg
- Investigational Product Name
- Benerva 300 mg compresse gastroresistenti
- Active Substance
- THIAMINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation in IT: marketingAuthNumber 004642031)
- Starting Dose
- 300 mg
- Maximum Dose
- 300 mg
- Investigational Product Name
- Placebo tablet matching Colchicina
- Modality
- Other
- Combination Treatment
- Yes
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