Statins In Intracerbral Hemorrhage

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT03936361
Phase
PHASE3
Status
Recruiting
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Conditions

  • Intracerebral Hemorrhage

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Statins — DRUG
    Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH

Study Details

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.

Key Dates

Start date
Jun 10, 2020
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
1,456 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

Recurrent symptomatic ICH [ Time Frame: within 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Magdy Selim, MD, PhD

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Beth Israel Deaconess Medical Center· Boston, MA

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