Phase 3 Stroke Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have had an acute stroke caused by a blocked blood vessel, and you are not eligible for the standard clot-busting injection (because too much time has passed) or for a procedure to physically remove the clot (because the blockage is not in one of the main large arteries).
- You had little or no disability in your daily life before this stroke (confirm with trial site).
- You are 18 years of age or older (there is no upper age limit).
- Your brain scans and/or symptoms show that there is still brain tissue that could potentially be saved, based on one of three specific patterns seen on imaging or symptom assessment (confirm with trial site for which pattern applies to you).
- You can begin treatment between 4.5 and 12 hours after you were last seen or known to be well — or, if you woke up with symptoms, within 12 hours of when you were last seen well.
- You, or someone legally able to speak for you, have given consent to take part.
Who may not be able to join:
- You have bleeding inside the brain, as shown on a scan.
- Your stroke symptoms are improving quickly on their own.
- You had significant disability before this stroke.
- You cannot have MRI or CT scans using contrast dye.
- Your brain scans show that a large portion of brain tissue has already been permanently damaged.
- You have taken part in another research study in the last 30 days.
- You have a serious illness that means you are not expected to live more than one year.
- Your platelet count (cells that help blood clot) is too low.
- You are a woman who could become pregnant and are known to be pregnant, or a pregnancy test on arrival comes back positive.
- You have had a stroke in the last three months.
- You have a history of bleeding in or around the brain, an abnormal tangle of blood vessels in the brain, a brain aneurysm, or a brain tumour (other than a specific non-harmful type called a meningioma).
- You are taking blood-thinning tablets (anticoagulants) and your blood-clotting test result is above a certain level.
- You have received a type of blood-thinning injection (heparin, other than a small preventative dose under the skin) in the last 48 hours and your clotting time is above the normal range.
- You have taken a specific type of anti-clotting medication called a glycoprotein IIb-IIIa inhibitor in the last 72 hours.
- Your blood sugar is dangerously low.
- Your blood pressure is very high and cannot be brought down to a safe level.
- You have a condition — inherited or developed — that makes you bleed easily.
- You have had bleeding from your stomach, gut, or urinary system in the last 21 days.
- You have had a major operation in the last 14 days that the trial doctor considers a risk.
- You have received a clot-busting treatment in the last 72 hours.
- You are already taking part in another study involving an experimental drug or device that could affect this trial.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Gisele Sampaio Silva, MD, MPH, PhD, Universidade Federal de São Paulo
Phone: 5511983580583
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.