SISTER Study: Investigating TS23 for Ischemic Stroke
This study, called SISTER, is testing a new treatment called TS23 for people who have had an acute ischemic stroke. TS23 is a monoclonal antibody, a type of protein that can target specific substances in the body. The study aims to see if TS23 is safe and effective in improving stroke recovery. You might be able to join if you are 18 or older, have had a suspected acute ischemic stroke affecting the front part of your brain, and have a certain level of stroke severity (NIH Stroke Scale score of 4 or more). Doctors will also look at your brain scans to make sure you have salvageable brain tissue. The study will enroll up to 300 participants and will measure safety by looking at any bleeding in the brain, and effectiveness by checking your stroke severity after treatment.
- Study design
- This is a Phase II, randomized, placebo-controlled, blinded study that will enroll up to 300 participants. It uses an adaptive design to test different doses of TS23 against a placebo.
- What's involved
- After providing informed consent, you would be randomized to receive one of four doses of TS23 or a placebo. Your stroke severity and any bleeding in the brain will be measured about 30 hours after receiving the study drug.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 90 (+/-7) days after receiving the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Strategy for Improving Stroke Treatment Response
At a glance
Conditions
Where it's being run
52 sites across 28 statesStudy leadership
- Eva Mistry, MBBS · PRINCIPAL_INVESTIGATOR · University of Cincinnati
Who to contact
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What this trial measures
- The proportion of patients with ANY intracerebral hemorrhage (ICH)At 30 (+/- 4) hours after study drug
Any ICH visualized on the follow-up CT scan
- Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS)At 30 (+/- 4) hours after study drug
NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke. The NIHSS will be adjusted for the baseline value in analysis.