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:

• People who have had a moderate to severe stroke, measured as a score of 8 or higher on a standard stroke severity scale (called the NIHSS)
• People who were largely independent and able to carry out all normal daily activities before their stroke (a pre-stroke score of 0 or 1 on a scale called the modified Rankin Scale)
• Adults aged 19 to 85 years old
• People who are able to receive standard clot-dissolving stroke treatment within 4.5 hours of their stroke symptoms starting
• People who are able to have a brain MRI scan
• People who give their consent to take part in the study

Who may not be able to join:

• People who have a history of serious allergic diseases or who are known to be allergic or sensitive to certain medications
• People who have had a heart attack within the past 6 months
• People who have had an irregular heartbeat causing symptoms such as shortness of breath or a racing/pounding heart within the past 6 months
• People whose heart electrical readings (ECG) at the Emergency Room show: a heart rate below 55 or above 120 beats per minute; a significant blockage in the heart's electrical signalling (2nd or 3rd degree AV block); a condition affecting the heart's electrical timing (congenital or acquired QT syndrome); or an abnormal electrical pathway in the heart (pre-excitation syndrome)
• People with severe heart failure, classified as NYHA Class III or Class IV (meaning significant or extreme limitations on physical activity)
• People with a fever of 38°C or higher, or signs of infection that require antibiotic treatment at the time of screening
• People with ongoing lung conditions (such as asthma, chronic obstructive pulmonary disease, or active tuberculosis) who have been receiving treatment for those conditions for more than one month at the time of screening
• People with low blood counts at the time of screening, specifically low haemoglobin, low platelet count, or low haematocrit (confirm exact thresholds with trial site)
• People who are currently receiving dialysis or being treated for kidney disease, whether acute or chronic, at the time of screening
• People with cancer who were diagnosed within the past 6 months, received any cancer treatment in the past 6 months, or whose cancer has returned or spread
• Women who are pregnant or breastfeeding; women of childbearing potential may only be considered if non-pregnancy is confirmed
• People who are not willing to use double barrier contraception for 90 days after receiving the first study treatment
• People who have taken part in another drug clinical trial within the past 3 months (those who participated in observation-only studies without taking any study drugs may still be considered)
• People who the trial investigators determine are unable to participate, for any reason
• People who are not able to receive the standard clot-dissolving stroke treatment (rtPA)

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