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 an acute ischemic stroke (a stroke caused by a blockage) and are eligible to receive a clot-dissolving medication given through a vein within 4.5 hours of the stroke starting.
• People who had little to no physical disability before the stroke occurred.
• People whose stroke severity score (measured by a standard medical scale called the NIHSS) is 6 points or higher before being enrolled.
• People aged 18 to 85 years old.
• People whose brain scans (such as a CT scan or MRI) show a blockage in a specific large blood vessel in or near the brain that is suitable for a procedure to physically remove the clot.
• People enrolled within 4.5 hours of when they were last seen or known to be well — including people who woke up with stroke symptoms, provided a specific type of brain scan (MRI) shows a particular pattern suggesting the stroke is recent enough (confirm with trial site).
• People (or their authorised representative) who have given informed consent to participate.

Who may not be able to join:

• People with known bleeding disorders, blood clotting problems, or who are taking blood-thinning medications above a certain level (including warfarin with a high INR, or newer blood thinners such as dabigatran, rivaroxaban, apixaban, or edoxaban taken within the last 48 hours).
• People whose platelet count (cells that help blood clot) is too low before the study begins.
• People whose blood sugar level is too low or too high at the start of the study.
• People with very high blood pressure that cannot be brought down to an acceptable level using standard medications.
• People who are in a coma or have a significantly reduced level of consciousness (with some exceptions for patients transported from another facility, confirm with trial site).
• People who had a seizure at the time the stroke began, which makes it impossible to properly assess their stroke severity.
• People with a serious or terminal illness where life expectancy is less than one year.
• People with a history of a severe life-threatening allergic reaction (more than a skin rash) to contrast dye used in scans.
• People who have already received IV clot-dissolving medication before being enrolled in the trial.
• People with significant kidney failure (based on a specific blood test result).
• People who are pregnant or who test positive for pregnancy on admission.
• People already taking part in another clinical trial involving an experimental drug or device that could affect this study.
• People with certain conditions affecting the brain's blood vessels, heart valve infection causing brain complications, or bleeding around the brain.
• People with a pre-existing neurological or psychiatric condition that would make it difficult to accurately assess their stroke recovery.
• People unlikely to be available for a follow-up appointment at 90 days (for example, people without a fixed home address or overseas visitors).
• People whose brain scans show that a large portion (more than one-third) of a specific brain region has already been affected by the stroke.
• People whose brain scan score (ASPECTS) is below 6, indicating extensive early stroke damage.
• People whose brain scan shows evidence of bleeding (with a small exception for a very limited number of tiny bleeds, confirm with trial site).
• People whose brain scan shows significant swelling causing a shift of brain structures.
• People where the blockage or the blood vessel pathway to reach it cannot be safely treated (for example, due to a blockage in the neck portion of a key artery, severe narrowing, a tear in the artery wall, or blood vessels that are too twisted to allow the procedure).
• People with blockages in more than one separate brain blood vessel territory at the same time.
• People with evidence of a brain tumour (except a small, non-aggressive type called a meningioma).

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