NCT03936361

Statins In Intracerbral Hemorrhage

STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,456 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype. An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on/off statin therapy.

Detailed description

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period. A subset of SATURN participants will participate in the optional MRI study, where they will undergo a baseline MRI within 7 days of randomization into SATURN and a repeat MRI at the end of the follow-up period. Recruitment will take place at \~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Statins	Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH

Timeline

• Start date: 2020-06-10
• Primary completion: 2027-06-30
• Completion: 2028-12-31
• First posted: 2019-05-03
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study