Statins In Intracerbral Hemorrhage (SATURN)
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ClinicalTrials.gov Identifier: NCT03936361 |
Recruitment Status :
Recruiting
First Posted : May 3, 2019
Last Update Posted : March 15, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | May 1, 2019 | ||||||
First Posted Date ICMJE | May 3, 2019 | ||||||
Last Update Posted Date | March 15, 2022 | ||||||
Actual Study Start Date ICMJE | June 10, 2020 | ||||||
Estimated Primary Completion Date | June 30, 2026 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Recurrent symptomatic ICH [ Time Frame: within 24 months ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Statins In Intracerbral Hemorrhage | ||||||
Official Title ICMJE | STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS | ||||||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants will be randomized at 1:1 ratio to either continue the same statin drug and dosage that they are taking at the time of ICH onset or to discontinue it for up to 24 months after ICH. No placebo will be prescribed for those randomized to discontinue statins. Masking: Single (Outcomes Assessor)Primary Purpose: Prevention |
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Condition ICMJE | Intracerebral Hemorrhage | ||||||
Intervention ICMJE | Drug: Statins
Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
Other Name: HMG CoA
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Study Arms ICMJE |
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Publications * | Szejko N, Kirsch E, Falcone GJ. Genetic determinants of LDL cholesterol and risk of intracerebral haemorrhage. Curr Opin Lipidol. 2021 Aug 1;32(4):244-248. doi: 10.1097/MOL.0000000000000761. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
1456 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2026 | ||||||
Estimated Primary Completion Date | June 30, 2026 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03936361 | ||||||
Other Study ID Numbers ICMJE | 2018C000515 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Magdy Selim, Beth Israel Deaconess Medical Center | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Beth Israel Deaconess Medical Center | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||
PRS Account | Beth Israel Deaconess Medical Center | ||||||
Verification Date | February 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |