Intracerebral HemorrhagePhase 3SATURNNCT03936361
Statins In Intracerbral Hemorrhage
A Phase 3 study testing Statins in people with Intracerebral Hemorrhage, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Statins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,456 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Magdy Selim, MD, PhD
About this study
Official title: STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
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.
Read the 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
- Being tested
- Statins
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinsDrug
Also called HMG CoA
Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
| Study group | Role | What they receive |
|---|---|---|
| Statin | Active comparator | The same statin agent and dose that subjects were using at the time of ICH onset. Receives: Drug: Statins |
| No-statin | No intervention | Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent symptomatic ICH
Measured: within 24 months
Secondary outcomes (1)
Major Adverse Cerebro- and Cardio-Vascular Events
Measured: Within 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start10 Jun 2020
- Primary completion31 Dec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NINDS Stroke Trials Network (StrokeNet), Canadian Stroke Consortium (CSC), University of Cincinnati, Medical University of South Carolina, Yale University, MetroHealth Medical Center, UH, Cleveland Medical Center, Corewell Health West, West Virginia University, Columbia University, Weill Medical College of Cornell University, New York Presbyterian Brooklyn Methodist Hospital, Buffalo General Medical Center, State University of New York - Upstate Medical University, St. Joseph's Regional Medical Center, New Jersey, Tufts Medical Center, Massachusetts General Hospital, UMass Memorial Health, Brigham and Women's Hospital, Baystate Medical Center, University of Vermont Medical Center, Lahey Hospital & Medical Center, Augusta University Medical Center, Prisma Health-Upstate, The Moses H. Cone Memorial Hospital, University of Virginia, George Washington University, University of Maryland, Baltimore, Mount Sinai Hospital, New York, NYU Langone Medical Center - Tisch Hospital, Montefiore Medical Center, NYU Langone Hospital - Brooklyn, Froedtert Hospital, Central DuPage Hospital, Rush University Medical Center, Loyola University, Stanford University, Mercy San Juan Medical Center, Oregon Health and Science University, Kaiser Permanente, University of Southern California, Cedars-Sinai Medical Center, University of New Mexico, Long Beach Memorial Medical Center, University of California, Irvine, Arrowhead Regional Medical Center, Huntington Memorial Hospital, Scripps Health, University of California, San Diego, Ochsner Health System, St. Joseph's Hospital and Medical Center, Phoenix, Desert Care Network, Eden Medical Center, San Francisco General Hospital, University of California, San Francisco, University of Louisville, Ohio State University, University of Iowa, Sanford Medical Center Fargo, University of Nebraska, Tampa General Hospital, University of Florida, Jackson Health System, Mayo Clinic, Baptist Medical Center Jacksonville, Wayne State University, University of Michigan, Mercy Health Saint Mary Grand Rapids, Metro Health, Michigan, University of Kentucky, McLaren Health Care, Regions Hospital, Allina Health System, University of Kansas, University of Minnesota, St. Cloud Hospital, Milton S. Hershey Medical Center, Abington Memorial Hospital, Temple University, University of Pennsylvania, Lehigh Valley Hospital, York Hospital, York, PA, Thomas Jefferson University, University of Pittsburgh, St. David's HealthCare, Baylor College of Medicine, Tulane Medical Center, The University of Texas Health Science Center at San Antonio, OU Medical Center, University of Utah, Swedish Medical Center, St. Mary's Medical Center, Banner University Medical Center, Intermountain Health Care, Inc., Legacy Emanuel Medical Center, Sacred Heart Medical Center Springfield, Harborview Injury Prevention and Research Center, University of Wisconsin, Madison, Aurora BayCare Medical Center, Wake Forest University Health Sciences, University of Alabama at Birmingham, University of South Alabama, Carolinas Medical Center, Barnes-Jewish Hospital, St. Luke's Hospital, Kansas City, Missouri, University of Arkansas, OSF Healthcare System, Cox Medical Center South, North Shore University Hospital, Rhode Island Hospital, Hartford Hospital, Staten Island University Hospital, Johns Hopkins University, University of North Carolina, Chapel Hill, University of Alberta, The Ottawa Hospital, London Health Sciences Centre, Hamilton General Hospital, Hopital de l'Enfant-Jesus, Montreal Neurological Institute and Hospital, Foothills Medical Centre, University Health Network, Toronto, Health Sciences Centre, Winnipeg, Manitoba, Thunder Bay Regional Health Sciences Centre, Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Fraser Health, Hopital de Chicoutimi, Université de Sherbrooke
- Responsible party
- Principal investigator, Magdy H Selim, MD, PhD, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936361
- Sponsor's protocol ID
- 2018C000515
- Acronym
- SATURN
- Status last verified
- Apr 2026
- First submitted
- 1 May 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marchina S, Yeatts SD, Foster LD, Janis S, Shoamanesh A, Khatri P, Bernstein K, Perlmutter A, Stever C, Heistand EC, Broderick JP, Greenberg SM, Leira EC, Rosand J, Lioutas VA, Salman RAS, Tirschwell D, Marti-Fabregas J, Selim M. Rationale and Design of the Statin Use in Intracerebral Hemorrhage Patients (SATURN) Trial. Cerebrovasc Dis. 2025;54(2):270-277. doi: 10.1159/000538195. Epub 2024 Mar 16.
PubMed 38493765Marchina S, Foster LD, Yeatts SD, Khatri P, Bernstein K, Perlmutter A, Heistand EC, Smith EE, Sharma M, Broderick JP, Lioutas VA, Marti-Fabregas J, Selim M, Shoamanesh A. SATURN MRI: study protocol for the statin use in intracerebral hemorrhage patients MRI ancillary study. Trials. 2025 Aug 30;26(1):323. doi: 10.1186/s13063-025-09024-0.
PubMed 40886018Zhao W, Yeatts SD, Broderick JP, Selim MH, Adeoye OM, Durkalski-Mauldin VL, Meinzer CN, Martin RH, Dillon CR, Cassarly CN, Pauls KH, Elm JJ. Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience. Stroke. 2023 Jul;54(7):1909-1919. doi: 10.1161/STROKEAHA.122.040743. Epub 2023 Apr 20.
PubMed 37078281Lee TC, Leung WC, Ho C, Chiu MW, Leung IY, Wong YK, Roxanna LK, Sum CH, Lui DT, Cheung RT, Leung GK, Chan KH, Teo KC, Lau KK. Association of LDL-cholesterol <1.8 mmol/L and statin use with the recurrence of intracerebral hemorrhage. Int J Stroke. 2024 Jul;19(6):695-704. doi: 10.1177/17474930241239523. Epub 2024 Mar 23.
PubMed 38429252Szejko 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.
PubMed 34010223
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
- ClinicalTrials.gov ID
- NCT03936361
- Acronym / sponsor ID
- SATURN / 2018C000515
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,456 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- NINDS Stroke Trials Network (StrokeNet), Canadian Stroke Consortium (CSC), University of Cincinnati, Medical University of South Carolina, Yale University, MetroHealth Medical Center, UH, Cleveland Medical Center, Corewell Health West, West Virginia University, Columbia University, Weill Medical College of Cornell University, New York Presbyterian Brooklyn Methodist Hospital, Buffalo General Medical Center, State University of New York - Upstate Medical University, St. Joseph's Regional Medical Center, New Jersey, Tufts Medical Center, Massachusetts General Hospital, UMass Memorial Health, Brigham and Women's Hospital, Baystate Medical Center, University of Vermont Medical Center, Lahey Hospital & Medical Center, Augusta University Medical Center, Prisma Health-Upstate, The Moses H. Cone Memorial Hospital, University of Virginia, George Washington University, University of Maryland, Baltimore, Mount Sinai Hospital, New York, NYU Langone Medical Center - Tisch Hospital, Montefiore Medical Center, NYU Langone Hospital - Brooklyn, Froedtert Hospital, Central DuPage Hospital, Rush University Medical Center, Loyola University, Stanford University, Mercy San Juan Medical Center, Oregon Health and Science University, Kaiser Permanente, University of Southern California, Cedars-Sinai Medical Center, University of New Mexico, Long Beach Memorial Medical Center, University of California, Irvine, Arrowhead Regional Medical Center, Huntington Memorial Hospital, Scripps Health, University of California, San Diego, Ochsner Health System, St. Joseph's Hospital and Medical Center, Phoenix, Desert Care Network, Eden Medical Center, San Francisco General Hospital, University of California, San Francisco, University of Louisville, Ohio State University, University of Iowa, Sanford Medical Center Fargo, University of Nebraska, Tampa General Hospital, University of Florida, Jackson Health System, Mayo Clinic, Baptist Medical Center Jacksonville, Wayne State University, University of Michigan, Mercy Health Saint Mary Grand Rapids, Metro Health, Michigan, University of Kentucky, McLaren Health Care, Regions Hospital, Allina Health System, University of Kansas, University of Minnesota, St. Cloud Hospital, Milton S. Hershey Medical Center, Abington Memorial Hospital, Temple University, University of Pennsylvania, Lehigh Valley Hospital, York Hospital, York, PA, Thomas Jefferson University, University of Pittsburgh, St. David's HealthCare, Baylor College of Medicine, Tulane Medical Center, The University of Texas Health Science Center at San Antonio, OU Medical Center, University of Utah, Swedish Medical Center, St. Mary's Medical Center, Banner University Medical Center, Intermountain Health Care, Inc., Legacy Emanuel Medical Center, Sacred Heart Medical Center Springfield, Harborview Injury Prevention and Research Center, University of Wisconsin, Madison, Aurora BayCare Medical Center, Wake Forest University Health Sciences, University of Alabama at Birmingham, University of South Alabama, Carolinas Medical Center, Barnes-Jewish Hospital, St. Luke's Hospital, Kansas City, Missouri, University of Arkansas, OSF Healthcare System, Cox Medical Center South, North Shore University Hospital, Rhode Island Hospital, Hartford Hospital, Staten Island University Hospital, Johns Hopkins University, University of North Carolina, Chapel Hill, University of Alberta, The Ottawa Hospital, London Health Sciences Centre, Hamilton General Hospital, Hopital de l'Enfant-Jesus, Montreal Neurological Institute and Hospital, Foothills Medical Centre, University Health Network, Toronto, Health Sciences Centre, Winnipeg, Manitoba, Thunder Bay Regional Health Sciences Centre, Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Fraser Health, Hopital de Chicoutimi, Université de Sherbrooke
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Statin | Active comparator | Drug: StatinsThe same statin agent and dose that subjects were using at the time of ICH onset. |
| No-statin | No intervention | –Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StatinsAlso: HMG CoAStatin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH | Drug | Statin |
Primary outcome
Recurrent symptomatic ICH
Time frame: within 24 months
1 secondary outcome
Major Adverse Cerebro- and Cardio-Vascular Events
Time frame: Within 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 38493765Marchina S, Yeatts SD, Foster LD, Janis S, Shoamanesh A, Khatri P, Bernstein K, Perlmutter A, Stever C, Heistand EC, Broderick JP, Greenberg SM, Leira EC, Rosand J, Lioutas VA, Salman RAS, Tirschwell D, Marti-Fabregas J, Selim M. Rationale and Design of the Statin Use in Intracerebral Hemorrhage Patients (SATURN) Trial. Cerebrovasc Dis. 2025;54(2):270-277. doi: 10.1159/000538195. Epub 2024 Mar 16.
- Background: PubMed 40886018Marchina S, Foster LD, Yeatts SD, Khatri P, Bernstein K, Perlmutter A, Heistand EC, Smith EE, Sharma M, Broderick JP, Lioutas VA, Marti-Fabregas J, Selim M, Shoamanesh A. SATURN MRI: study protocol for the statin use in intracerebral hemorrhage patients MRI ancillary study. Trials. 2025 Aug 30;26(1):323. doi: 10.1186/s13063-025-09024-0.
- Background: PubMed 37078281Zhao W, Yeatts SD, Broderick JP, Selim MH, Adeoye OM, Durkalski-Mauldin VL, Meinzer CN, Martin RH, Dillon CR, Cassarly CN, Pauls KH, Elm JJ. Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience. Stroke. 2023 Jul;54(7):1909-1919. doi: 10.1161/STROKEAHA.122.040743. Epub 2023 Apr 20.
- Derived from this study: PubMed 38429252Lee TC, Leung WC, Ho C, Chiu MW, Leung IY, Wong YK, Roxanna LK, Sum CH, Lui DT, Cheung RT, Leung GK, Chan KH, Teo KC, Lau KK. Association of LDL-cholesterol <1.8 mmol/L and statin use with the recurrence of intracerebral hemorrhage. Int J Stroke. 2024 Jul;19(6):695-704. doi: 10.1177/17474930241239523. Epub 2024 Mar 23.
- Derived from this study: PubMed 34010223Szejko 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.
- Individual participant dataSharing planned: No
Related trials for Intracerebral Hemorrhage
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
RecruitingObservational study
INTERACT4 Expansion - Validation Study
Intracerebral Hemorrhage
Enrolling by invitationEarly Phase 1
Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.
Moyamoya Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Statins in people with Intracerebral Hemorrhage, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdy Selim, MD, PhD (617-632-8917, mselim@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent symptomatic ICH (time frame: within 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936361, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.