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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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.
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage||Drug: Statins||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1456 participants|
|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)|
|Official Title:||STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS|
|Actual Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||June 30, 2026|
|Estimated Study Completion Date :||December 31, 2026|
Active Comparator: Statin
The same statin agent and dose that subjects were using at the time of ICH onset.
Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
Other Name: HMG CoA
No Intervention: No-statin
Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.
- Recurrent symptomatic ICH [ Time Frame: within 24 months ]
- Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ]
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥ 50 years.
- Spontaneous lobar ICH confirmed by CT or MRI scan
- Patient was taking a statin drug at the onset of the qualifying/index ICH
- Randomization can be carried out within 7 days of the onset of the qualifying ICH
- Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation
- Suspected secondary cause for the qualifying ICH, such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.
- History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
- Diabetic patients with history of myocardial infarction or coronary revascularization
- History of familial hypercholesterolemia
- Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
- Known diagnosis of severe dementia
- Inability to obtain informed consent
- Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits/assessments.
- Life expectancy of less than 24 months due to co-morbid terminal conditions.
- Pre-morbid mRS >3
- ICH score >3 upon presentation.
- Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
- Woman of childbearing potential
- Concurrent participation in another research protocol for investigation of experimental therapy.
- Indication that withdrawal of care will be implemented for the qualifying ICH.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936361
|Contact: Magdy Selim, MD, PhDemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Magdy Selim, MD, PhD|
|Responsible Party:||Magdy Selim, Professor of Neurology, Beth Israel Deaconess Medical Center|
|Other Study ID Numbers:||
|First Posted:||May 3, 2019 Key Record Dates|
|Last Update Posted:||March 15, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Central Nervous System Diseases
Nervous System Diseases