Use of statins in patients with intracerebral hemorrhage

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511465-11-00

Acronym

SATURN

Enrollment

180

Registered

2024-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous lobar ICH

Brief summary

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

Detailed description

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

Interventions

DRUGSimvastatina NORMON 10 mg comprimidos recubiertos con película EFG

DRUGAtorvastatina NORMON 20 mg comprimidos recubiertos con película EFG

DRUGSimvastatina NORMON 40 mg comprimidos recubiertos con película EFG

DRUGAtorvastatina NORMON 40 mg comprimidos recubiertos con película EFG

DRUGAtorvastatina NORMON 10 mg comprimidos recubiertos con película EFG

DRUGAtorvastatina Normon 60 mg comprimidos recubiertos con película

DRUGSimvastatina NORMON 20 mg comprimidos recubiertos con película EFG

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026