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SISTER

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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 placebo. The trial will enroll up to 300 subjects at up to 60 participating US sites and up to 17 Canadian sites.

The effects of TS23 will be evaluated on two following primary outcomes using a utility

Function: 1) primary safety outcome: any intracerebral hemorrhage at 30 (+/-4) hours and

  1. primary efficacy outcome: NIH Stroke Scale score at 30 (+/-4. hours after drug administration. The study will follow participants for 90 (+/-7) days.

Primary Objective: To identify a dose of Ts23 that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of last known well, who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.

Details

Full study title Strategy for Improving Stroke Treatment Response Trial
Protocol number OCR45043
ClinicalTrials.gov ID NCT05948566
Phase Phase 2

Eligibility

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

Lead researcher

  • Amita Singh, MD, MS
    Neurologist, Vascular Neurologist (Brain Blood Vessel Specialist)
    Amita Singh

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  1. Step
    1

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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