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 18 years or older.
• People who have had a suspected acute ischemic stroke (a stroke caused by a blockage) in the front part of the brain.
• People whose stroke symptoms began between 4.5 and 24 hours before joining the trial, including those who woke up with stroke symptoms or whose stroke was not witnessed — in these cases, "onset time" means the last time the person was known to be well.
• People whose stroke severity falls within a specific range on a standard medical scoring scale (a score of 6 to 25 on the NIHSS, which measures stroke symptoms).
• People whose brain CT scan shows only limited early signs of stroke-related changes.
• People who have given written consent to participate, or whose legal representative has done so on their behalf.

Who may not be able to join:

• People whose CT scan shows a clearly visible area of brain damage from the current stroke, where the treating doctor judges there is little expected benefit from treatment.
• People found to have bleeding in or around the brain on their CT scan.
• People for whom a procedure to physically remove a blood clot from a blood vessel (thrombectomy) is already planned at the time of enrolment.
• People who had some level of disability before the stroke (confirm with trial site).
• People with a known allergy to the trial drug or any of its ingredients.
• People who have had a severe head injury or another stroke in the past 3 months.
• People who have had surgery inside the brain or spine within the 3 months before joining.
• People known to have a brain tumour or a large aneurysm (a bulge in a blood vessel) in the brain.
• People who have had bleeding in the stomach, bowel, or urinary system within the past 3 weeks.
• People who have active internal bleeding at the time of enrolment.
• People with a confirmed tear in the main artery leading from the heart (aortic dissection).
• People with a confirmed infection of the heart valves (infective endocarditis).
• People with a low platelet count (below 100 × 10⁹/L), which affects the blood's ability to clot.
• People who have received blood-thinning injections (heparin or low-molecular-weight heparin) within the 24 hours before enrolment.
• People who are pregnant or breastfeeding.
• People whose blood sugar level is very low (below 50 mg/dL) or very high (above 400 mg/dL) at the time of screening.
• People with very high blood pressure that cannot be brought under control with medication (systolic above 185 mmHg or diastolic above 110 mmHg).
• People with a life expectancy of less than 6 months due to cancer, severe heart or lung disease, or another terminal illness.
• People who are already taking part in another clinical trial.
• People the investigator considers unsuitable for the study for other reasons, such as being unable to understand or follow the study procedures or attend follow-up appointments due to a mental health condition, cognitive difficulties, or emotional disorder.

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