Clinical trial • Phase II • Neurology
SIMVASTATIN for Spontaneous lobar intracerebral hemorrhage
Phase II trial of SIMVASTATIN for Spontaneous lobar intracerebral hemorrhage.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Spontaneous lobar intracerebral hemorrhage
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-11-2024
- First CTIS Authorization Date
- 20-11-2024
Trial design
Randomised, continuation (restart) of participant's statin therapy vs. discontinuation of statin therapy; no specific dose or schedule stated.-controlled Phase II trial in Spain.
- Randomised
- Yes
- Comparator
- Continuation (restart) of participant's statin therapy vs. discontinuation of statin therapy; no specific dose or schedule stated.
- Target Sample Size
- 1276
- Trial Duration For Participant
- 730
Eligibility
Recruits 1276 Legal authorised representative (LAR) may provide consent: 'Patient or LAR, after consultation with the physicians prescribing statin, agrees to be randomized to statin continuation (restart) vs. discontinuation'. Inability to obtain informed consent is an exclusion ('Inability to obtain informed consent'). The trial does not select vulnerable populations (isVulnerablePopulationSelected: false)..
- Pregnancy Exclusion
- Women of childbearing potential
- Vulnerable Population
- Legal authorised representative (LAR) may provide consent: 'Patient or LAR, after consultation with the physicians prescribing statin, agrees to be randomized to statin continuation (restart) vs. discontinuation'. Inability to obtain informed consent is an exclusion ('Inability to obtain informed consent'). The trial does not select vulnerable populations (isVulnerablePopulationSelected: false).
Inclusion criteria
- {"criterion_text":"- Age ≥ 50 years.\n- Spontaneous lobar ICH confirmed by CT or MRI scan\n- Patient was taking a statin drug at the onset of the qualifying/index ICH\n- Randomization must be carried out within 7 days of the onset of the qualifying ICH\n- Patient or LAR, after consultation with the physicians prescribing statin, agrees to be randomized to statin continuation (restart) vs. discontinuation"}
Exclusion criteria
- {"criterion_text":"- Suspected secondary cause for the qualifying ICH, such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.\n- Pre-morbid mRS >3\n- ICH score >3 upon presentation.\n- Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis\n- Concurrent participation in another research protocol for investigation of experimental therapy\n- Women of childbearing potential\n- Indication that withdrawal of care will be implemented for the qualifying ICH.\n- History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months\n- Diabetic patients with history of myocardial infarction or coronary revascularization\n- History of familial hypercholesterolemia\n- Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors\n- Known diagnosis of severe dementia\n- Inability to obtain informed consent\n- Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits/assessments.\n- Life expectancy of less than 24 months due to co-morbid terminal conditions."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The main efficacy endpoint is the impact of continuing vs. discontinuing statins on the risk of recurrent symptomatic intracerebral hemorrhage (ICH) over a 24-month follow-up period. The safety primary endpoint focuses on the occurrence of major adverse cardiac and cerebrovascular events (MACCE), including ischemic stroke, myocardial infarction, and vascular death","definition_or_measurement_approach":"Efficacy: recurrent symptomatic ICH assessed over a 24-month follow-up period. Safety: occurrence of MACCE (including ischemic stroke, myocardial infarction, newly symptomatic arterial occlusive disease, revascularization procedures, and vascular death) during 24 months."}
Secondary endpoints
- {"endpoint_text":"- Secondary endpoints include quality of life, cognitive and functional outcomes, measured through the EQ-5D questionnaire, modified Rankin Scale (mRS), and Telephone Montreal Cognitive Assessment (T-MoCA). Additionally, the document examines the effects of APOE ε4 and ε2 genotypes on the risk of recurrent ICH","definition_or_measurement_approach":"Quality of life, cognitive and functional outcomes measured by repeated assessments of EQ-5D, mRS and T-MoCA at 3, 6, 9, 12, 18 and 24 months. Genetic effect modification assessed by presence vs. absence of APOE ε4 and APOE ε2 genotypes."}
Recruitment
- Planned Sample Size
- 1276
- Recruitment Window Months
- 84
- Consent Approach
- Consent is obtained from the patient or the patient's legal authorised representative (LAR): 'Patient or LAR, after consultation with the physicians prescribing statin, agrees to be randomized to statin continuation (restart) vs. discontinuation'. Inability to obtain informed consent is an exclusion ('Inability to obtain informed consent'). Subject information and informed consent form documents are provided (L1_SIS and ICF_for publication). Translations are present (Spanish translations of titles/information are included).
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 1276
Spain
- Earliest CTIS Part Ii Submission Date
- 19-11-2024
- Latest Decision Or Authorization Date
- 12-05-2025
- Processing Time Days
- 174
- Number Of Sites
- 30
- Number Of Participants
- 180
Sites
- Site Name
- Hospital Universitario Donostia
- Department Name
- Neurology
- Principal Investigator Name
- PATRICIA DE LA RIVA JUEZ
- Principal Investigator Email
- patricia.delariva@gmail.com
- Contact Person Name
- PATRICIA DE LA RIVA JUEZ
- Contact Person Email
- patricia.delariva@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Neurology
- Principal Investigator Name
- Pachi Moniche
- Principal Investigator Email
- pmoniche@gmail.com
- Contact Person Name
- Pachi Moniche
- Contact Person Email
- pmoniche@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Neurology
- Principal Investigator Name
- Blanca Fuentes
- Principal Investigator Email
- blanca.fuentes@salud.madrid.org
- Contact Person Name
- Blanca Fuentes
- Contact Person Email
- blanca.fuentes@salud.madrid.org
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Neurology
- Principal Investigator Name
- Maria Esther Ramos Araque
- Principal Investigator Email
- ramosmaryesther@gmail.com
- Contact Person Name
- Maria Esther Ramos Araque
- Contact Person Email
- ramosmaryesther@gmail.com
- Site Name
- Universidade De Santiago De Compostela
- Department Name
- Neurology
- Principal Investigator Name
- Susana Arias
- Principal Investigator Email
- susanaarias2001@gmail.com
- Contact Person Name
- Susana Arias
- Contact Person Email
- susanaarias2001@gmail.com
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- Neurology
- Principal Investigator Name
- Juan Carlos Portilla Cuenca
- Principal Investigator Email
- portilla7819@yahoo.es
- Contact Person Name
- Juan Carlos Portilla Cuenca
- Contact Person Email
- portilla7819@yahoo.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Neurology
- Principal Investigator Name
- María del Mar Castellanos Rodrigo
- Principal Investigator Email
- maria.del.mar.castellanos.rodrigo@sergas.es
- Contact Person Name
- María del Mar Castellanos Rodrigo
- Contact Person Email
- maria.del.mar.castellanos.rodrigo@sergas.es
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Neurology
- Principal Investigator Name
- José María Ramírez Moreno
- Principal Investigator Email
- jramrez@unex.es
- Contact Person Name
- José María Ramírez Moreno
- Contact Person Email
- jramrez@unex.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Neurology
- Principal Investigator Name
- Marta Serrano
- Principal Investigator Email
- mserranop@gmail.com
- Contact Person Name
- Marta Serrano
- Contact Person Email
- mserranop@gmail.com
- Site Name
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Department Name
- Neurology
- Principal Investigator Name
- Jerzy Krupinski
- Principal Investigator Email
- jkrupinski@mutuaterrassa.es
- Contact Person Name
- Jerzy Krupinski
- Contact Person Email
- jkrupinski@mutuaterrassa.es
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Neurology
- Principal Investigator Name
- Yolanda Silva
- Principal Investigator Email
- ysilva.girona.ics@gencat.cat
- Contact Person Name
- Yolanda Silva
- Contact Person Email
- ysilva.girona.ics@gencat.cat
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Neurology
- Principal Investigator Name
- Mari Mar Freijo Guerrero
- Principal Investigator Email
- marfreijo1064@icloud.com
- Contact Person Name
- Mari Mar Freijo Guerrero
- Contact Person Email
- marfreijo1064@icloud.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurology
- Principal Investigator Name
- Rocío Vera
- Principal Investigator Email
- rocio.vera@salud.madrid.org
- Contact Person Name
- Rocío Vera
- Contact Person Email
- rocio.vera@salud.madrid.org
- Site Name
- Bellvitge University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Pere Cardona
- Principal Investigator Email
- pcardonap@bellvitgehospital.cat
- Contact Person Name
- Pere Cardona
- Contact Person Email
- pcardonap@bellvitgehospital.cat
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Neurology
- Principal Investigator Name
- FRANCISCO PURROY
- Principal Investigator Email
- fpurroygarcia@gmail.com
- Contact Person Name
- FRANCISCO PURROY
- Contact Person Email
- fpurroygarcia@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Neurology
- Principal Investigator Name
- Oriol Barachina
- Principal Investigator Email
- obarrachina@tauli.cat
- Contact Person Name
- Oriol Barachina
- Contact Person Email
- obarrachina@tauli.cat
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Neurology
- Principal Investigator Name
- Elena López-Cancio
- Principal Investigator Email
- elenacancio@gmail.com
- Contact Person Name
- Elena López-Cancio
- Contact Person Email
- elenacancio@gmail.com
- Site Name
- University Hospital Son Espases
- Department Name
- Neurology
- Principal Investigator Name
- Silvia Tur Campos
- Principal Investigator Email
- silvia.tur@ssib.es
- Contact Person Name
- Silvia Tur Campos
- Contact Person Email
- silvia.tur@ssib.es
- Site Name
- Hospital Universitari Joan XXIII De Tarragona
- Department Name
- Neurology
- Principal Investigator Name
- Xavier Ustrell
- Principal Investigator Email
- xustrell.hj23.ics@gencat.cat
- Contact Person Name
- Xavier Ustrell
- Contact Person Email
- xustrell.hj23.ics@gencat.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- David Rodríguez Luna
- Principal Investigator Email
- rodriguezluna@vhebron.net
- Contact Person Name
- David Rodríguez Luna
- Contact Person Email
- rodriguezluna@vhebron.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Neurology
- Principal Investigator Name
- Xabier Urra Nuin
- Principal Investigator Email
- xurra@clinic.cat
- Contact Person Name
- Xabier Urra Nuin
- Contact Person Email
- xurra@clinic.cat
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Neurology
- Principal Investigator Name
- Mercedes de Lera
- Principal Investigator Email
- mercele23@gmail.com
- Contact Person Name
- Mercedes de Lera
- Contact Person Email
- mercele23@gmail.com
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- Neurology
- Principal Investigator Name
- Oscar Ayo Martin
- Principal Investigator Email
- oscarayo@gmail.com
- Contact Person Name
- Oscar Ayo Martin
- Contact Person Email
- oscarayo@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Neurology
- Principal Investigator Name
- Laia Figueras Aguirre
- Principal Investigator Email
- glfigueras@tauli.cat
- Contact Person Name
- Laia Figueras Aguirre
- Contact Person Email
- glfigueras@tauli.cat
- Site Name
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Principal Investigator Name
- Joan Martí-Fàbregas
- Principal Investigator Email
- jmarti@santpau.cat
- Contact Person Name
- Joan Martí-Fàbregas
- Contact Person Email
- jmarti@santpau.cat
- Site Name
- Hospital Del Mar
- Department Name
- Neurology
- Principal Investigator Name
- Ana Rodríguez Campello
- Principal Investigator Email
- arodriguezc@hospitaldelmar.cat
- Contact Person Name
- Ana Rodríguez Campello
- Contact Person Email
- arodriguezc@hospitaldelmar.cat
- Site Name
- Hospital Universitario Torrecardenas
- Department Name
- Neurology
- Principal Investigator Name
- PATRICIA MARTÍNEZ SÁNCHEZ
- Principal Investigator Email
- patrindalo@hotmail.com
- Contact Person Name
- PATRICIA MARTÍNEZ SÁNCHEZ
- Contact Person Email
- patrindalo@hotmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Neurology
- Principal Investigator Name
- Juanjo Soria
- Principal Investigator Email
- juanjst@gmail.com
- Contact Person Name
- Juanjo Soria
- Contact Person Email
- juanjst@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Neurology
- Principal Investigator Name
- José Vivancos
- Principal Investigator Email
- jvivancos@neurogps.com.es
- Contact Person Name
- José Vivancos
- Contact Person Email
- jvivancos@neurogps.com.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- José Tembl
- Principal Investigator Email
- tembl_jos@gva.es
- Contact Person Name
- José Tembl
- Contact Person Email
- tembl_jos@gva.es
Sponsor
Primary sponsor
- Full Name
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Simvastatina NORMON (10 mg / 20 mg / 40 mg film-coated tablets)
- Active Substance
- SIMVASTATIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber(s) listed in product data)
- Dose Levels
- 10 mg | 20 mg | 40 mg
- Maximum Dose
- 80 mg
- Investigational Product Name
- Atorvastatina NORMON (10 mg / 20 mg / 40 mg / 60 mg film-coated tablets)
- Active Substance
- ATORVASTATIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber(s) listed in product data)
- Dose Levels
- 10 mg | 20 mg | 40 mg | 60 mg
- Maximum Dose
- 80 mg
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