Statins In Intracerbral Hemorrhage
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- STATUS
- Recruiting
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- End date
- Dec 31, 2026
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- participants needed
- 1456
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- sponsor
- Beth Israel Deaconess Medical Center
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.
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.
Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.
Details
| Condition | hemorrhage cerebral, Cerebral Hemorrhage, intracerebral hemorrhage, intracerebral hemorrhage (ich), intracerebral haemorrhage, cerebral bleeding |
|---|---|
| Treatment | statins |
| Clinical Study Identifier | NCT03936361 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Last Modified on | 30 July 2021 |
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