Phase 3 Stroke Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older
• People who can begin treatment within 4.5 hours of when they were last known to be well (this is used as the stroke onset time)
• People diagnosed with a minor stroke, with a low stroke severity score (NIHSS of 5 or less), and who still have ongoing weakness in one arm or leg, or difficulty with speech
• People who were mostly independent before the stroke (with little to no disability in daily life beforehand)
• People who have given written informed consent to participate

Who may not be able to join:

• People who are planned to receive, or are likely to receive, an emergency procedure to open a blocked blood vessel before being enrolled in the trial
• People with a low level of consciousness based on their stroke assessment score (NIHSS consciousness item greater than 2)
• People with a known allergy to rhTNK-tPA (the study drug)
• People with a history of bleeding inside the brain
• People who have had a serious head injury or a stroke in the past 3 months
• People who have had brain or spinal surgery in the past 3 months
• People who have had bleeding in the stomach, bowel, or urinary tract in the past 3 weeks
• People who have had major surgery in the past 2 weeks
• People who have had a needle inserted into an artery that cannot be easily compressed to stop bleeding, within the past week
• People with certain brain conditions including some types of brain tumours, large brain aneurysms, or abnormal tangles of blood vessels in the brain
• People with any current bleeding inside the brain (of any type)
• People with active bleeding inside the body (internal bleeding)
• People with a tear in the main artery leading from the heart (aortic dissection)
• People with a tendency to bleed actively, including a low platelet count or other related conditions
• People with high blood pressure that remains uncontrolled even after treatment (top number above 180 mmHg or bottom number above 100 mmHg)
• People whose blood sugar level is too low (below 2.8 mmol/L) or too high (above 22.2 mmol/L)
• People taking blood-thinning medication such as warfarin, where blood test results show the blood is too thin (INR above 1.7 or PT above 15 seconds)
• People who have used heparin (a blood-thinning medicine) in the past 24 hours
• People who have taken certain other blood-thinning medicines (thrombin inhibitors or factor Xa inhibitors) in the past 48 hours
• People whose brain scans show a large area of stroke affecting more than one-third of a major brain region (middle cerebral artery territory)
• People whose weakness may be caused by a seizure rather than a stroke, or people with other neurological or psychiatric conditions that would affect their ability to cooperate with the trial
• People with severe, uncontrolled infections such as certain heart or pancreas infections
• People who are pregnant, breastfeeding, or unwilling to use effective contraception during the study
• People who have taken part in another clinical trial within the past 3 months
• People with serious illnesses where life expectancy is less than six months
• People considered unsuitable for the trial or at higher risk by the trial investigator's judgement (confirm with trial site)

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