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Monoclonal Antibodies
TS23 for Stroke (SISTER Trial)
Charlottesville, VA
Phase 2
Recruiting
Led By Eva Mistry, MBBS
Research Sponsored by Translational Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and older
Suspected anterior circulation acute ischemic stroke
Must not have
Persistent systolic blood pressure >180mmHg or diastolic blood pressure >105mmHg despite best medical management
Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 (±1) h, and 30 (±4) h, 30 (±5) days, and 90 (±7) days, after completion of study drug administration.
Summary
This trial is testing a new drug called TS23 in patients who have had a stroke. It is a Phase-II trial, which means it is still in the early stages of testing. The trial will
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Who is the study for?
This trial is for adults 18+ who've had a stroke affecting the brain's anterior circulation, with specific imaging results showing a moderate to severe impact. They must be able to start treatment within 4.5 to 24 hours after the stroke or when they were last known well.Check my eligibility
What is being tested?
The SISTER trial is testing TS23, an antibody targeting a clotting factor in blood, as a new treatment for acute ischemic strokes. Participants are randomly chosen to receive either TS23 or a placebo without knowing which one they get.See study design
What are the potential side effects?
While not specified here, monoclonal antibodies like TS23 can cause allergic reactions, infusion-related discomforts, and may affect bleeding or clotting mechanisms due to their action on blood proteins.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am suspected to have a stroke affecting the front part of my brain.
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My brain scans show a specific level of stroke damage that meets the trial's criteria.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure remains high despite taking medication.
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I haven't taken blood thinners like argatroban or dabigatran in the last 48 hours.
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I do not have any neurological or psychiatric conditions that could affect brain function tests.
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I was mostly independent before my stroke.
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I have a bleeding disorder or take blood thinners with an INR over 1.7.
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I have not had a serious bleeding issue in the last 30 days.
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I have had a stroke in the last 3 months.
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My creatinine levels are above 4 mg/dl or I am on dialysis.
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I have taken a full dose of heparin or similar medications in the last 24 hours.
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I am scheduled for a procedure involving the inside of my blood vessels.
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I have received or will receive a clot-dissolving medication through an IV.
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I have had a brain bleed, tumor, stroke, or abnormal blood vessels in my brain.
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I showed signs of a specific type of brain bleed, even though my first brain scan was clear.
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I am currently dealing with a heart attack, blood clot in my lung or leg, or another clotting issue needing blood thinners.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 (±1) h, and 30 (±4) h, 30 (±5) days, and 90 (±7) days, after completion of study drug administration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 (±1) h, and 30 (±4) h, 30 (±5) days, and 90 (±7) days, after completion of study drug administration.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS)
The proportion of patients with ANY intracerebral hemorrhage (ICH)
Secondary study objectives
% brain tissue reperfusion
Evaluation of anti-drug antibodies
Frequency of excellent functional outcome
+10 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 4 TS23Experimental Treatment1 Intervention
highest dose
Group II: Dose 3 TS23Experimental Treatment1 Intervention
next higher dose
Group III: Dose 2 TS23Experimental Treatment1 Intervention
next higher dose
Group IV: Dose 1 TS23Experimental Treatment1 Intervention
low dose
Group V: PlaceboPlacebo Group1 Intervention
Placebo
Find a Location
Closest Location:UVA Medical Center· Charlottesville, VA
Who is running the clinical trial?
Medical University of South CarolinaOTHER
986 Previous Clinical Trials
7,406,538 Total Patients Enrolled
74 Trials studying Stroke
62,065 Patients Enrolled for Stroke
National Institutes for Neurologic Disorders and Stroke (NINDS)UNKNOWN
Translational Sciences, Inc.Lead Sponsor
2 Previous Clinical Trials
56 Total Patients Enrolled
University of ArizonaOTHER
540 Previous Clinical Trials
160,013 Total Patients Enrolled
3 Trials studying Stroke
267 Patients Enrolled for Stroke
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,390 Previous Clinical Trials
655,492 Total Patients Enrolled
179 Trials studying Stroke
81,131 Patients Enrolled for Stroke
University of CincinnatiOTHER
440 Previous Clinical Trials
638,449 Total Patients Enrolled
32 Trials studying Stroke
14,543 Patients Enrolled for Stroke
Eva Mistry, MBBSPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Stroke
120 Patients Enrolled for Stroke