Strategy for Improving Stroke Treatment Response
ConditionIschemic Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTranslational Sciences, Inc.
About this trial
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and older
Suspected anterior circulation acute ischemic stroke
NIH Stroke Scale score ≥4 prior to randomization
ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI)
Disqualifiers
Received endovascular treatment with clot engagement.
Patients who undergo groin puncture but clot engagement is not attempted due to spontaneous distal migration are permitted to be enrolled in the trial if all other eligibility criteria are met.
Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted.
Received or planned to receive intravenous thrombolysis.
Trial design
Design model
Parallel
Treatments tested in this trial
TS23
Biological/VaccineMonoclonal antibody
Treatment groups
300 Participants
are divided into 5 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Dose 1 TS23Experimental treatment 1 intervention
Group C: Dose 2 TS23Experimental treatment 1 intervention
Group D: Dose 3 TS23Experimental treatment 1 intervention
Group E: Dose 4 TS23Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients with ANY intracerebral hemorrhage (ICH)
Any ICH visualized on the follow-up CT scan
Time frame
At 30 (+/- 4) hours after study drug2
Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS)
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.
Time frame
At 30 (+/- 4) hours after study drugSecondary outcomes
1
Improvement in level of global disability measured by modified Rankin Score (mRS distribution)
The modified Rankin Score assessment is a 7-level disability scale that measures the degree of disability or dependence in daily activities of people who have suffered a stroke. Range 0= no disability and 6=dead.
Time frame
90 (±7) days2
Frequency of Modified Rankin (mRS) score of 0-1 or returning to pre-stroke mRS.
Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS.
Time frame
Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS at 90 (+/-7) days.3
NIHSS
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.
Time frame
72 (±12) hours (or at discharge if sooner) after study drug administration.4
α2-antiplasmin (a2AP) level in plasma
A serine protease inhibitor responsible for inactivating plasmin.
Time frame
at 3 (±1) h after completion of study drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Translational Sciences, Inc.
Lead sponsor
University of Cincinnati
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Medical University of South Carolina
Collaborator
University of Arizona
Collaborator
Source ClinicalTrials.gov