Evaluating statin use after brain hemorrhage

STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS

This study is testing whether people who have had a brain bleed should keep taking their statin medications to see if it helps prevent more brain bleeds and other serious health problems.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1456 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03936361 on ClinicalTrials.gov

What this trial studies

The SATURN trial investigates whether patients who experience spontaneous lobar intracerebral hemorrhage (ICH) should continue or discontinue their statin medications. This multi-center, randomized clinical trial will enroll 1,456 patients within 7 days of their ICH event, assessing the impact of statin therapy on the recurrence of ICH and major adverse cerebro-/cardio-vascular events over a 24-month follow-up period. Additionally, a subset of participants will undergo MRI scans to evaluate the effects of statin therapy on cerebral small vessel disease markers. The study will also consider the influence of the APOE genotype on treatment decisions.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older who have experienced a spontaneous lobar ICH while on statin therapy.

Not a fit: Patients with secondary causes of ICH or significant cardiovascular history may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the optimal management of statin therapy in patients recovering from intracerebral hemorrhage.

How similar studies have performed: While there have been studies on statin use in various conditions, this specific approach to ICH management is novel and has not been extensively tested.

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.

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Magdy Selim, MD, PhD

Conditions Intracerebral Hemorrhage