RecruitingIschemic Stroke

Strategy for Improving Stroke Treatment Response

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

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About this study

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.

Sponsor: Translational Sciences, Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 1. Received endovascular treatment with clot engagement.
✕ 1. 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.
✕ 2. Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted.
✕ 2. Received or planned to receive intravenous thrombolysis.
✕ 3. Pre-stroke modified Rankin score \>2.
✕ 4. Previous treatment with TS23 or known previous allergy to antibody therapy.
✕ 5. Known pregnancy, women who are breastfeeding or plan to breastfeed within 3 months of receiving TS23 or have a positive urine or serum pregnancy test for women of childbearing potential.
✕ 6. Known previous stroke in the past 90 days.