Phase 3 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 between 18 and 90 years old
• People weighing between 40 kg and 166 kg
• People for whom treatment can begin within 24 hours of when they were last known to be well before their stroke symptoms started
• People whose stroke severity score (measured by a standard medical scale called the NIHSS) is between 5 and 15 around the time of joining the trial — including people whose stroke initially seemed mild but got worse over time, reaching that range (confirm with trial site)
• People who were largely independent before their stroke, with little or no disability beforehand (a pre-stroke score of 0 or 1 on a scale called the mRS)
• People who received clot-dissolving treatment (fibrinolytics) within 4.5 hours of stroke onset may still be considered, provided certain additional conditions are met — including that their stroke severity score was 15 or below before that treatment, remained between 5 and 15 at least 6 hours after treatment, and improved by fewer than 4 points (or got worse) after that treatment, along with repeat brain imaging showing no bleeding (confirm with trial site)
• People who are able to give informed consent themselves, or whose legally authorised representative can do so on their behalf
• People who, in the investigator's judgement, are able and willing to follow the study plan

Who may not be able to join:

• People whose brain imaging confirms a bleeding (haemorrhagic) stroke
• People whose imaging shows a large artery blockage in certain specific locations in the brain or brainstem blood vessels (confirm with trial site for exact locations)
• People with a very large area of established brain damage, as measured by a brain imaging scoring system (an ASPECTS score of 0–5)
• People who are having or will have a mechanical procedure to remove a blood clot (mechanical thrombectomy) for this stroke
• People with a suspected or confirmed tear in an artery in the neck (extracranial arterial dissection)
• People whose imaging or symptoms point to a stroke affecting the brainstem or cerebellum (the lower and back parts of the brain) — though strokes affecting the posterior cerebral artery alone, without brainstem or cerebellar involvement, may be acceptable
• People who have had any recorded blood pressure reading that was very low (systolic below 100 mmHg or mean arterial pressure below 65 mmHg) after the stroke started and before joining the trial
• People currently taking a type of blood pressure medication called an ACE inhibitor (ACEi) who are unable or unwilling to switch to a different blood pressure medication for the duration of the study
• People currently taking an ACE inhibitor who took their last dose fewer than 24 hours before the study treatment infusion would start
• People who have a history of serious allergic reactions — such as severe swelling (angioedema) or anaphylaxis — that required hospitalisation
• People who have, or are suspected to have, a condition called hereditary angioedema (HAE), or who are taking medications commonly used to treat or prevent HAE (confirm with trial site for the specific medications listed)
• People whose life expectancy is estimated at one year or less before joining the trial
• People with signs of an active infection at the time of joining that requires intravenous (IV) treatment or hospitalisation — note that simple infections treated with oral antibiotics (such as a urinary tract or sinus infection) would not prevent participation
• People with a known condition called alpha-1 antitrypsin deficiency
• People who are pregnant or breastfeeding — note that people who agree to stop breastfeeding may be considered at the investigator's discretion
• People who are able to become pregnant and are not willing to use two reliable forms of contraception during the study and until the Day 90 visit, or who are not willing to avoid attempts to become pregnant or undergo IVF during this period — a negative pregnancy test is also required at screening (confirm with trial site for accepted contraception methods)
• People who have taken part in another clinical trial involving an investigational drug or device within the 30 days before screening
• People who do not have suitable vein access for the study infusion or blood tests
• People who are unable or unwilling to attend the required assessments, tests, and follow-up visits
• People with any other medical condition that, in the investigator's opinion, would make participation unsafe or affect the study results

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