STATINS USE IN INRACEREBRAL HEMORRHAGE PATIENTS (SATURN)

Brief description of study

This 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 (restarting) of statin therapy (using the same agent and dose that they were using at ICH onset). Randomization will take into account: clinical site, statin dose and indication (primary vs. secondary prevention), current use and intent-to-use oral anticoagulants (OAC) and/or antiplatelets in the long-term post-ICH, and severity of ICH upon presentation as assessed by baseline ICH volume. 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 MACCE during the follow-up period.


Clinical Study Identifier: s19-01927
ClinicalTrials.gov Identifier: NCT03936361
Principal Investigator: Jennifer A. Frontera.


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