Phase 3 Stroke Trial, Recruiting NCT05892510 Sponsor: University of Melbourne Condition: Stroke
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Phase 3 Stroke Trial, Recruiting

NCT05892510
Recruiting Phase 3 🇦🇺 Australian site

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:

  • Adults aged 18 or older who have had an ischemic stroke (a stroke caused by a blockage) with a large blood vessel blockage in the brain, confirmed by a CT or MRI scan of specific arteries (the internal carotid artery or the main middle brain artery)
  • People who are being treated with a clot-removal procedure (thrombectomy) within 24 hours of their stroke starting
  • People whose stroke started 0–6 hours ago and whose brain scan shows enough healthy brain tissue remaining (an ASPECTS score of 3 or higher on the standard CT scan)
  • People whose stroke started 6–24 hours ago and whose specialised brain scan shows a smaller affected area of less than 100ml
  • People whose qualifying brain scan was done within 4 hours of being enrolled in the trial (if transferred from another hospital, a repeat CT scan may be needed)
  • People who were largely independent before their stroke, with only mild or no pre-existing disability (a Modified Rankin Scale score of 2 or less)
  • People for whom the legal consent requirements in their location have been met

Who may not be able to join:

  • People who have bleeding in the brain, as shown on a CT or MRI scan
  • People whose brain scan shows very extensive stroke damage (an ASPECTS score of 0–2)
  • People whose specialised brain scan shows a large affected area of more than 100ml, when their stroke started 6–24 hours ago
  • People who are expected to need a stent placed in the blood vessels of the brain or neck during their procedure
  • People for whom more than six attempts have already been made to remove the clot in the same blood vessel
  • People who received the clot-dissolving drug alteplase within 30 minutes before the trial drug would be given
  • People who cannot have contrast dye used during imaging scans
  • People who, in the medical team's judgement, have a condition that could make the trial treatment unsafe (confirm with trial site)
  • Women who are pregnant
  • People currently participating in another research study that involves experimental treatments beyond standard care
  • People taking blood-thinning medications in certain circumstances — though people on warfarin with an INR of 1.7 or below, or people on dabigatran who have received a reversal treatment called idarucizumab, may still be considered
  • People who have other standard medical reasons that would normally prevent the use of clot-dissolving treatments (confirm with trial site)
  • People with a known terminal illness where survival beyond one year would not be expected
  • People for whom withdrawal of active medical care or comfort-only care is already planned

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 15 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

Phone: +03 9342 7000

Australian sites

Gold Coast Univeristy Hospital, Gold Coast, Queensland
Royal Adelaide Hospital, Adelaide,
Alfred Hospital, Melbourne,
Austin Hospital, Melbourne,
Monash Medical Centre, Melbourne,
Royal Melbourne Hospital, Melbourne,
Fiona Stanley Hospital, Perth,
Sir Charles Gairdner Hospital, Perth,
Liverpool Hospital, Sydney,
Royal North Shore Hospital, Sydney,
Townsville University Hospital, Townsville,

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
University of Melbourne
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
30 August 2027

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand

11 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Early Neurological Improvement (Phase 2b); Functional independence (Phase 3)

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: 15 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