SISTER: Strategy for Improving Stroke Treatment Response

Sponsor

Translational Sciences, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05948566

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

SISTER is a Phase-2, 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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Biological: TS23	Phase 2

Detailed Description

The primary objective is 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 ischemic stroke onset (or last known well), who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Strategy for Improving Stroke Treatment Response

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Jul 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Biological: TS23 Monoclonal antibody
Experimental: Dose 1 TS23 low dose	Biological: TS23 Monoclonal antibody
Experimental: Dose 2 TS23 next higher dose	Biological: TS23 Monoclonal antibody
Experimental: Dose 3 TS23 next higher dose	Biological: TS23 Monoclonal antibody
Experimental: Dose 4 TS23 highest dose	Biological: TS23 Monoclonal antibody

Outcome Measures

Primary Outcome Measures

Safety - intracranial hemorrhage [At 30 (+/- 4) hours after study drug]
any intracranial hemorrhage
Efficacy - neurological disability [At 30 (+/- 4) hours after study drug]
NIH Stroke Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years and older
Suspected anterior circulation acute ischemic stroke
Presenting NIH Stroke Scale score >/= 6
Favorable baseline neuroimaging
CT scan with ASPECTS of >/=6, or MRI with ASPECTS of >/=7 and
CT or MR Perfusion with a mismatch ratio >1.2 between the volume of hypoperfusion and the volume of the ischemic core, an absolute difference in volume > 10 ml, and an ischemic-core volume of less than 70 ml. and
Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well
Informed consent for the study participation obtained from participant or their legally authorized representatives.

Exclusion Criteria:

Patients planned to receive endovascular treatment.
Patients that received or planned to receive intravenous thrombolysis.
Pre-stroke modified Rankin score >2.
Known previous allergy to antibody therapy.
Known pregnancy or positive urine or serum pregnancy test for women of child bearing potential.
Known previous stroke in the past 90 days.
Known previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal.
Surgery or biopsy of parenchymal organ in the past 30 days.
Known trauma with internal injuries or ulcerative wounds in the past 30 days.
Severe head trauma in the past 90 days.
Persistent systolic blood pressure >180mmHg or diastolic blood pressure >105mmHg despite best medical management.
Serious systemic hemorrhage in the past 30 days.
Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >1.7.
Platelets <100,000/mm3.
Hematocrit <25 %.
Elevated PTT above laboratory upper limit of normal.
Creatinine > 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine.
Received heparin or low molecular weight heparins (such as dalteparin, enoxaparin, tinzaparin) in full dose within the previous 24 hours.
Received Factor Xa inhibitors (such as fondaparinux, apixaban or rivaroxaban) within the past 48 hours.
Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours.
Received glycoprotein IIb/IIIa inhibitors within the past 14 days.
Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations.
Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days).
Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Translational Sciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Translational Sciences, Inc.

ClinicalTrials.gov Identifier:

NCT05948566

Other Study ID Numbers:

TS23-U202

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 18, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Study Results

No Results Posted as of Jul 18, 2023