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 to 85 years old (both ages included), of any gender
• People who have been diagnosed with an acute ischaemic stroke (a stroke caused by a blocked blood vessel) according to Chinese clinical guidelines
• People whose stroke severity score (called the NIHSS) is between 8 and 25 before being assigned to a treatment group, and whose arm and leg weakness scores together add up to at least 2
• People who are within 3 hours of their stroke starting and are expected to begin receiving the trial treatment within that 3-hour window (if the stroke happened during sleep, the start time is counted from when the person was last seen to be well)
• People experiencing their first ever stroke, or people who have had a stroke before but made a good recovery (with a disability score of 1 or less on the mRS scale)
• People who are able to understand and follow the study procedures, and who are willing to sign a consent form — either personally or through a legal representative — agreeing to take part

Who may not be able to join:

• People whose brain scans show any type of bleeding in or around the brain (such as a bleed caused by stroke, trauma, or other causes)
• People with a severe reduced level of consciousness, indicated by a score of 2 or more on a specific part of the NIHSS assessment
• People whose blood pressure remains very high (top number 180 mmHg or above, or bottom number 110 mmHg or above) even after treatment to lower it
• People with severely abnormal blood sugar levels — either very high (at or above 400 mg/dL) or very low (at or below 50 mg/dL)
• People with a heart rate below 50 or above 120 beats per minute, or people who have had heart failure, unstable chest pain, a heart attack, or a serious irregular heartbeat within the past 6 months
• People with a previously diagnosed serious liver or kidney condition that the trial doctors determine could affect their participation
• People who have had a cancer diagnosis or have been receiving cancer treatment within the past 5 years
• People who have already received neuroprotective treatment (medicines aimed at protecting brain cells) after the current stroke began
• People with a history of epilepsy (seizures), or who have had a seizure after the current stroke began
• People with a mental health condition that means they are unable or unwilling to cooperate with the study
• People with conditions affecting their limbs — such as poor circulation in the legs or joint disease — that the trial doctors determine would interfere with tests of movement and nerve function
• People who have had a serious head injury or stroke within the 3 months before joining the study
• People with a history of severe allergies to food or medicine, or who are known to be allergic to the trial drug or any of its ingredients
• People whose life expectancy is less than 3 months
• People who are pregnant, planning to become pregnant, or currently breastfeeding
• People with a suspected or confirmed history of alcohol or drug misuse
• People who have taken part in another clinical trial of a drug or medical device within the past month, or who are currently in another clinical trial
• People with any other condition that the trial doctors consider would increase risk or make participation unsuitable (confirm with trial site)

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