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:

• The patient or their legally authorised representative has signed the consent form agreeing to participate
• Adults aged 18 years or older
• People who, in the investigator's judgement, are able to follow the study procedures
• People experiencing an acute ischemic stroke (a stroke caused by a blocked artery) in the front part of the brain, involving a large blocked artery (the internal carotid artery or the first part of the middle cerebral artery), confirmed by imaging, and being treated with a procedure to remove the clot
• People with a stroke severity score of 6 or higher (on a standard medical scale) at the time the clot-removal procedure begins
• People where the stroke began, or where they were last known to be well, less than 24 hours before the study drug would be given
• People whose brain scan shows a score of 6 or higher on a standard scale measuring how much of the brain is affected (confirm with trial site)
• People treated more than 6 hours after stroke onset must have a specific type of brain scan showing a favourable pattern, meaning a small area of brain already damaged (under 70 mL), with a much larger area at risk but still potentially saveable (confirm with trial site)
• People whose qualifying brain scans were taken within 120 minutes before the clot-removal procedure begins

Who may not be able to join:

• People currently taking part in another clinical trial of an investigational drug or device
• People with a known allergy or sensitivity to tenecteplase or any of its ingredients
• People with active internal bleeding at the time of the trial
• People with a known bleeding disorder, including Alzheimer's patients taking the medication lecanemab
• People with a hereditary or acquired condition affecting blood clotting, a clotting factor deficiency, or those on blood-thinning tablets with a specific blood test result (INR) above 1.7
• People who have taken certain newer blood-thinning medications (dabigatran, rivaroxaban, apixaban, or edoxaban) within the past 48 hours
• People who have received a clot-dissolving (thrombolytic) treatment within the past 3 months, including clot-dissolving treatment given during this current stroke
• People whose platelet count (cells that help blood clot) is below 100,000 per microlitre on their baseline blood test
• People whose blood sugar level is above 400 mg/dL at the start
• People whose blood sugar level is below 50 mg/dL, unless it has been brought back to a normal level before joining the trial
• People who have had brain or spinal surgery, or a serious head or spine injury, within the past 2 months
• People with another serious, advanced, or terminal illness, or whose life expectancy is less than 6 months
• People who have had an ischemic stroke in the past 90 days
• People with a history of a bleeding stroke (hemorrhagic stroke)
• People where the stroke is suspected to be caused by an infected clot or bacterial heart infection
• People where the investigator judges that the clot-removal procedure would be unsafe or not appropriate for any other reason
• People who are pregnant
• People with blood pressure that remains too high (systolic above 185 mmHg or diastolic above 110 mmHg) even after attempts to lower it
• People where a tear in the main artery from the heart (aortic dissection) is suspected
• People with a known allergy to iodine or the contrast dye used in imaging procedures
• People who require kidney dialysis (haemodialysis or peritoneal dialysis), or who have a medical reason they cannot undergo an angiogram
• People with significant kidney failure, as indicated by specific blood test results (confirm with trial site)
• People with a known brain tumour
• People who have had gastrointestinal (gut) bleeding within the past 21 days
• People with a pre-existing medical or neurological condition that would make it difficult to assess stroke recovery
• People who were already significantly disabled before this stroke, rated 3 or higher on a standard disability scale (modified Rankin Scale)
• People whose pre-procedure brain scan shows too much brain already damaged (score below 6 on the ASPECTS scale)
• People whose brain scan shows bleeding in the brain or leakage of contrast dye before or immediately after the clot-removal procedure
• People whose brain scan shows significant swelling causing the brain to shift to one side
• People in whom a stent was placed in a neck or brain artery during the clot-removal procedure
• People found to have multiple blocked arteries in different areas of the brain at the same time, confirmed on imaging

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