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 aged 18 or older
• People whose stroke symptoms began no more than 4.5 hours before treatment (based on the last time they were known to be well)
• People whose brain imaging (CT or MRI scan with dye) shows a blocked artery in a specific area of the brain, including the internal carotid artery, anterior cerebral artery, posterior cerebral artery, certain sections of the middle cerebral artery, or the basilar artery
• People who were largely independent in daily life before the stroke (a disability score of 2 or less on a standard scale)
• People, or their legally authorised representative, who are able to give consent to take part

Who may not be able to join:

• People whose brain scan shows a bleeding stroke or blood clot outside the brain (such as a bleed within brain tissue, in the fluid around the brain, or between the brain and skull)
• People who cannot have imaging scans that use a contrast dye (for example, due to an allergy or kidney problems) (confirm with trial site)
• People who are in a coma at the time of assessment
• People with a previous history of bleeding inside the brain
• People who have had a serious head injury or stroke in the past 3 months
• People who have had surgery inside the brain or spine in the past 3 months
• People who have had major surgery in the past 2 weeks
• People who have had bleeding in the stomach, bowel, or urinary tract in the past 3 weeks
• People with a tumour inside the brain, an abnormal tangle of blood vessels in the brain, or a very large brain aneurysm
• People with active internal bleeding anywhere in the body
• People with a tear in the body's main artery (the aorta)
• People who have had a needle inserted into an artery in a location that cannot be safely compressed in the past week
• People with blood pressure that remains very high (above 180/100 mmHg) despite treatment to lower it
• People with a tendency to bleed easily, including a low platelet count (below 100 × 10⁹/L)
• People who have received a blood-thinning medication called heparin in the past 24 hours
• People taking blood-thinning tablets (anticoagulants) whose blood clotting test results are above certain levels (INR above 1.7 or PT above 15 seconds)
• People who have taken certain blood-thinning medications (direct thrombin inhibitors or direct Factor Xa inhibitors) in the past 48 hours
• People whose blood sugar level is either very low (below 2.8 mmol/L) or very high (above 22.2 mmol/L)
• People whose brain scan shows a large area of the brain already affected by the stroke (more than one-third of the middle cerebral artery region, or a similar proportion of another area)
• People whose stroke symptoms are improving rapidly, as assessed by the trial doctor
• People who have taken part in another clinical trial in the past 30 days
• People with a serious illness where life expectancy is estimated to be less than one year
• People where the trial doctor believes participation may pose a risk to their health or wellbeing
• People who are pregnant
• People with a known allergy to the trial medications (Alteplase or Tenecteplase) or any of their ingredients

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