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SATURN


Title Statins Use In Intracerebral Hemorrhage Patients
Therapeutic Area Intracerebral Hemorrhage
Principal Investigator Joshua Kornbluth, MD
Min Age 50 Years
Gender All
Contact Emma Jost-Price
617-636-7606
neuroresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03936361

Overview

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.

Study Details

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Requirements

Patients are eligible for consent while they are inpatient, within 7 days of onset of hemorrhage. There will be a blood sample of 20 mL collected and sent to the central lab for gene testing. There may be one additional blood draw of 10 mL if cholesterol testing has not been done through standard of care prior to enrollment. There are required follow up assessments, via phone call or mail, at 1, 2, 3, 6, 9, 12, 18, and 24 months. Phone calls will last between 15 and 30 minutes.