SATURN

Description

Purpose: To determine the effects of continuation vs. discontinuation of statins on the risk of ICH recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar intracerebral hemorrhage (ICH) while taking a statin drug. Specifically, we wish to determine the effects of discontinuing vs. continuing statins on the risk of recurrent symptomatic ICH

Description: 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 (restarting) of statin therapy (using the same agent and dose that they were using at ICH Onset.

Participating subjects will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) during the follow-up period.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

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 must be carried out within 7 days of the onset of the qualifying ICH
Patient or legally authorized representative, after consultation with physicians, agrees to be randomized to statin continuation (restart) vs. discontinuation

To Participate: “Please contact the Network Office of Research and Innovation at 610-402-9543.”

For more information: https://clinicaltrials.gov/ct2/show/NCT03936361?term=SATURN&draw=2&rank=8