Phase 2 Stroke Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 years or older
• People who are suspected to have had an acute ischemic stroke affecting the front part of the brain
• People with a stroke severity score of 4 or higher on a standard medical scale before being enrolled (if the score is 4–5, the stroke must be causing a clearly disabling problem)
• People whose brain scans show a favorable pattern, meaning enough salvageable brain tissue compared to already-damaged tissue, based on specific measurements from CT or MRI imaging (confirm details with trial site)
• People who are able to receive the study drug between 4.5 and 24 hours after their stroke started, or after they were last seen to be well
• People who are able to receive the study drug within 120 minutes of the qualifying brain scan (within 90 minutes is preferred; if more than 120 minutes pass, another scan is required)
• People, or their legally authorised representative, who have given informed consent to participate in the study

Who may not be able to join:

• People who have already received an endovascular procedure where the clot was engaged (a procedure that goes through a blood vessel to reach the clot); note that people who had the procedure started but the clot was not reached due to it moving on its own may still be eligible (confirm with trial site)
• People who have received, or are planned to receive, a clot-dissolving drug given through a vein (intravenous thrombolysis)
• People who had significant disability before the stroke, based on a standard disability rating scale score above 2
• People who have previously been treated with the study drug TS23, or who are known to have had an allergic reaction to antibody-based treatments
• People who are known to be pregnant, are breastfeeding, plan to breastfeed within 3 months of receiving the study drug, or have a positive pregnancy test (applies to women who could become pregnant)
• People who are known to have had a stroke in the past 90 days
• People with a known history of bleeding in the brain, a brain tumour, bleeding around the brain (subarachnoid haemorrhage), or an abnormal tangle of blood vessels in the brain
• People with a known active brain tumour
• People whose symptoms suggest bleeding around the brain, even if the initial CT scan appeared normal
• People who have had surgery or a biopsy of an internal organ in the past 30 days
• People who have had a known injury with internal injuries or persistent open wounds in the past 30 days
• People who have had a severe head injury in the past 90 days
• People with persistently high blood pressure (above 180/105 mmHg) that has not responded to treatment
• People who have had a serious bleed anywhere in the body in the past 30 days
• People with known bleeding disorders, clotting factor problems, or who are on blood-thinning medication with a clotting measure (INR) above 1.7
• People with a low platelet count (below 100,000/mm³)
• People with a low red blood cell level (haematocrit below 25%)
• People with an elevated aPTT blood test result above the normal range for the testing laboratory
• People with significantly reduced kidney function (creatinine above 4 mg/dl) or who are on kidney dialysis
• People who have received certain blood-thinning medications recently, including unfractionated heparin (within 24 hours, unless blood clotting levels are back to normal), full-dose low molecular weight heparin such as enoxaparin or dalteparin (within 24 hours), Factor Xa inhibitors such as apixaban or rivaroxaban (within 48 hours), direct thrombin inhibitors such as dabigatran or argatroban (within 48 hours), or glycoprotein IIb/IIIa inhibitors (within 14 days)
• People with a known pre-existing neurological or psychiatric condition that would affect the ability to assess stroke-related outcomes
• People currently participating in another research drug treatment study (a waiting period of 90 days after this trial would apply before joining another experimental drug study)
• People who are currently experiencing another clotting event such as a heart attack, pulmonary embolism, or deep vein thrombosis that requires blood-thinning treatment

Important: Always verify eligibility with the trial site directly before applying.