Statins In Intracerbral Hemorrhage (SATURN)

• ClinicalTrials.gov Identifier: NCT03936361
• Recruitment Status: Recruiting
• First Posted: May 3, 2019
• Last Update Posted: July 23, 2021
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: NINDS Stroke Trials Network (StrokeNet); Canadian Stroke Consortium (CSC); University of Cincinnati; Medical University of South Carolina
• Information provided by (Responsible Party): Magdy Selim, Beth Israel Deaconess Medical Center

Tracking Information

• First Submitted Date: May 1, 2019
• First Posted Date: May 3, 2019
• Last Update Posted Date: July 23, 2021
• Actual Study Start Date: June 10, 2020
• Estimated Primary Completion Date: June 30, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 1, 2019): Recurrent symptomatic ICH [ Time Frame: within 24 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 1, 2019): Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Statins In Intracerbral Hemorrhage
• Official Title: 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.

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.

Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Intracerebral Hemorrhage

Intervention

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

Study Arms

• Active Comparator: Statin
  The same statin agent and dose that subjects were using at the time of ICH onset.
  Intervention: Drug: Statins
• 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.

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 1, 2019): 1456
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: June 30, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age ≥ 50 years.
2. Spontaneous lobar ICH confirmed by CT or MRI scan
3. Patient was taking a statin drug at the onset of the qualifying/index ICH
4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
5. Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation

Exclusion Criteria:

1. 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.
2. History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
3. Diabetic patients with history of myocardial infarction or coronary revascularization
4. History of familial hypercholesterolemia
5. Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
6. Known diagnosis of severe dementia
7. Inability to obtain informed consent
8. 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.
9. Life expectancy of less than 24 months due to co-morbid terminal conditions.
10. Pre-morbid mRS >3
11. ICH score >3 upon presentation.
12. Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
13. Woman of childbearing potential
14. Concurrent participation in another research protocol for investigation of experimental therapy.
15. Indication that withdrawal of care will be implemented for the qualifying ICH.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Magdy Selim, MD, PhD; 617-632-8913; mselim@bidmc.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03936361
• Other Study ID Numbers: 2018C000515
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Magdy Selim, Beth Israel Deaconess Medical Center
• Study Sponsor: Beth Israel Deaconess Medical Center

Collaborators

• NINDS Stroke Trials Network (StrokeNet)
• Canadian Stroke Consortium (CSC)
• University of Cincinnati
• Medical University of South Carolina

• Investigators: Not Provided
• PRS Account: Beth Israel Deaconess Medical Center
• Verification Date: July 2021