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:

• Adults between 18 and 80 years of age (inclusive)
• People who have had a spontaneous brain bleed (one that occurred on its own, not from an outside cause)
• People for whom the study treatment can be given within 120 minutes of when the stroke started or when the person was last seen well, and who show a specific marker on a brain scan suggesting active bleeding, OR people who can be treated within 90 minutes with or without that marker present
• People for whom consent has been obtained following emergency research consent guidelines, as required by the country where the trial is being conducted

Who may not be able to join:

• People who score between 3 and 7 on the Glasgow Coma Scale, which is a measure of consciousness and responsiveness — a lower score indicates a more severe reduction in consciousness
• People whose brain bleed is caused by a known condition, such as a head injury, a burst blood vessel (aneurysm), an abnormal tangle of blood vessels (AVM), use of blood-thinning medications in the past 7 days, or a blood clotting disorder
• People whose brain bleed is smaller than 2 cc or 60 cc or larger in volume
• People where blood is filling two-thirds or more of one of the brain's fluid-filled chambers, or at least one-third of both of those chambers
• People who already had a significant level of disability before this event, based on a standard disability scale score above 2
• People who have had a blood clot–related event in the past 90 days, such as a stroke, heart attack, blood clot in the lungs, deep vein clot, or unstable chest pain
• People showing signs on a heart tracing (ECG) that suggest an active heart attack
• People whose brain bleed is located in the brainstem (those with bleeding in the cerebellum may still be considered)
• People where the patient, their legal representative, or a family member has refused participation
• People with a known or suspected low platelet count, unless a recent test confirms platelets are above 50,000 per microlitre
• People receiving a certain type of blood-thinning medication (unfractionated heparin) who also have an abnormal clotting test result
• People who have taken certain clot-promoting medications, such as tranexamic acid or aminocaproic acid, within the 24 hours before enrolment
• People who have received a different type of blood-thinning injection (low-molecular-weight heparin) within the past 24 hours
• People who have had a neck artery surgery or a heart or brain artery procedure within the past 90 days
• People with a serious or terminal illness, or any other condition the investigating doctor considers would make the study treatment unsafe for them
• People who have taken part in another clinical drug or device trial within the past 30 days, or in any earlier trial whose effects may still be ongoing
• People for whom withdrawal of active treatment or comfort-only care is already planned
• People who the trial team believes would not be able to follow the trial procedures, for example due to alcohol dependence, drug dependence, or a psychological condition
• People with a known or suspected allergy to the study medication, its ingredients, or related products
• People for whom the study medication is otherwise medically contraindicated
• People who have already taken part in this trial previously
• People who are female, of childbearing potential, and are known to be pregnant, within 12 weeks after giving birth, or currently breastfeeding at the time of enrolment

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