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 aged 18 years or older
• People who have been clinically diagnosed with an acute ischemic stroke (a stroke caused by a blocked blood vessel in the brain)
• People who have taken a blood-thinning medication called a DOAC (such as rivaroxaban, apixaban, or dabigatran) within 48 hours before joining the trial, or who are on ongoing DOAC therapy but cannot remember exactly when the last dose was taken (note: if enough participants in this category have already been enrolled, this window may be shortened to within 24 hours only — confirm with trial site)
• People for whom the trial treatment (a clot-dissolving medication or placebo) can be started either within 4.5 hours of when the person was last known to be well, OR between 4.5 and 24 hours after that time if brain imaging shows a specific pattern indicating salvageable brain tissue that meets certain size and blood flow measurements
• People with a stroke severity score (called NIHSS) between 4 and 25, OR people with a lower score of 0–3 if the stroke is causing a significant disability such as vision loss, speech difficulty, weakness, or another serious neurological problem as judged by the treating doctor
• People who are able to provide written consent themselves, or whose legally authorised representative is able to do so on their behalf

Who may not be able to join:

• People who have bleeding in or around the brain confirmed by a brain scan, or who have a history of any bleeding inside the skull
• People who have a known allergy to the medication tenecteplase
• People who had significant disability in daily functioning before the stroke (confirm with trial site for exact definition)
• People who are planned to have an endovascular procedure (a procedure to physically remove the clot through a blood vessel)
• People currently taking two different antiplatelet (anti-clotting) medications at the same time as their DOAC
• People who are planned to receive a medication to reverse the effects of their DOAC (such as idarucizumab, andexanet, or tranexamic acid)
• People whose brain scan shows a large area of early stroke damage affecting roughly one third or more of a major brain region
• People who have had a serious head injury or other major trauma in the past 3 months
• People found to have a brain tumour, abnormal blood vessel tangle (arteriovenous malformation), or a large aneurysm (10mm or larger) before joining the trial
• People who have had brain surgery, spinal surgery, or other major surgery within the past 3 months
• People who have had bleeding from the stomach, bowel, or urinary system in the past 3 weeks
• People who have active internal bleeding at the time of screening
• People with a confirmed tear in the main artery from the heart (aortic dissection)
• People with a confirmed infection of the heart valves (infective endocarditis)
• People with a low platelet count (below 100 × 10⁹/L), which affects the blood's ability to clot
• People who have received heparin or a related blood-thinning injection within 24 hours before joining the trial
• People who are pregnant or breastfeeding
• People whose blood sugar level is very low or very high at the time of screening
• People with very high blood pressure that cannot be brought under control with medication (above 185/110 mmHg)
• People whose life expectancy is less than 6 months due to cancer, severe heart or lung disease, or another serious terminal illness
• People who are currently participating in another clinical trial
• People who, in the judgement of the investigator, are unable to understand or follow the study procedures or attend follow-up appointments due to a mental health condition, cognitive difficulties, or emotional disorder

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