Strategy for Improving Stroke Treatment Response (SISTER) Trial
Translational Sciences, Inc.
Summary
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.
Description
SISTER is a Phase II, Bayesian, adaptive, randomized, dose-finding trial of TS23 in patients with acute ischemic stroke. Patients with an anterior cerebral circulation acute ischemic stroke and present between 4.5 to 24 hours of their last known well with a presenting NIH Stroke Scale Score \>/=4 (with the patient having a clearly disabling deficit if the NIHSS is 4 or 5) and an imaging evidence of salvageable brain tissue will be eligible and will be approached for an informed consent for study participation. After informed consent is provided, the study will randomize to 4 doses of TS23 and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years and older 2. Suspected anterior circulation acute ischemic stroke 3. NIH Stroke Scale score ≥4 prior to randomization a. The participant must have a clearly disabling deficit if NIHSS is 4-5. 4. Favorable baseline neuroimaging consisting of all of the following: 1. ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI) 2. Favorable perfusion imaging on CT perfusion (CTP)/MR-perfusion weighted imaging (PWI) consisting of all of the following: i. Mismatch ratio of penumbra: core \>1.2 ii. Mismatch volume \>10 cc iii. Core \<70 cc c. If CT hyp…
Interventions
- BiologicalTS23
Monoclonal antibody
Locations (52)
- University of Alabama HospitalBirmingham, Alabama
- Banner University Medical CenterPhoenix, Arizona
- Mayo Clinic PhoenixPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona
- UCSD Health La JollaLa Jolla, California
- Kaiser Permanente Los AngelesLos Angeles, California