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
Qualifiers
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
Treatments tested in this trial
- TS23
Treatment groups
300 Participants
are divided into 5 treatment groupsSponsors and collaborators
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