Phase 3 Stroke Trial, Recruiting NCT05199662 Sponsor: Hospital Moinhos de Vento Condition: Stroke
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Phase 3 Stroke Trial, Recruiting

NCT05199662
Recruiting Phase 3

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 3
Sponsor
Hospital Moinhos de Vento
Registry
ClinicalTrials.gov
Start date
20 January 2022
Est. completion
1 July 2026

Where this trial is recruiting

🇧🇷 Brazil

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov