Phase 3 study for people with Stroke

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Boehringer Ingelheim
Registry number NCT07361302
Started 17 February 2026 Today 16 October 2026 Estimated completion 2 October 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Campbelltown Hospital Campbelltown NSW Recruiting
Liverpool Hospital Liverpool NSW Recruiting
John Hunter Hospital New Lambton Heights NSW Recruiting
Royal Adelaide Hospital Adelaide SA Recruiting
Eastern Health-Box Hill Hospital Box Hill VIC Recruiting
Monash Medical Centre Clayton VIC Recruiting
Royal Melbourne Hospital Parkville VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 1325

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion criteria:

1. Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years

2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

3. Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well \>4.5 h before time of presumed randomisation

4. Pre-stroke modified Rankin scale (mRS) ≤1

5. Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)

Exclusion criteria:

1. Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation

2. Occlusion of the internal carotid artery (ICA)

3. High-risk patients (increased risk of thrombolysis related hemorrhage)

4. Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans

5. Contra-indication to contrast brain imaging with CT and MRI

6. Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) \> 25)

7. Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator

8. Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h

9. Patients scheduled to receive intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.

Dates on the record

Started 17 February 2026
Estimated completion 2 October 2027
Registry last updated 13 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 13 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.