NoNO-42 Trial in Acute Ischemic Stroke Patients Selected for Thrombolysis With or Without Endovascular Thrombectomy
Recruiting now · Phase 2
Conditions studied: Acute Ischemic Stroke
In brief
ACT-42 is a domain of the ACT-GLOBAL platform (NCT06352632). This trial is a Phase 2b, multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive trial. A total of up to 600 male and female participants aged ≥ 18 to ≤ 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 4.5 hours of stroke onset/last known well.
Key facts
- Study ID
- NCT06403267
- Run by
- NoNO Inc.
- People needed
- 600
- Starts
- 2024-10-02
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-07-15
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed or suspected acute ischemic stroke (AIS) selected for intravenous thrombolysis.
- Onset (last-known-well) time to randomization time within 4.5 hours.
- Ages ≥ 18 to ≤ 90 years.
- Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS) >5.
- Confirmed or suspected symptomatic anterior circulation intracranial occlusion. Tandem extracranial carotid and intracranial occlusions are permitted.
- Pre-stroke independent functional status in activities of daily living as judged by the enrolling physician. Patient must be living without requiring nursing care.
- Consent process completed as per national laws and regulation and the applicable ethics committee requirements.
You may not qualify if…
- Large extent early ischemic changes/infarct in the ischemic territory on qualifying imaging.
- Any intracranial hemorrhage on qualifying imaging.
- Unlikely to initiate study drug administration before arterial puncture in those selected for EVT.
- Known/suspected pregnancy and/or lactation.
- Systolic blood pressure < 90 mmHg
- Known prior receipt of NoNO-42 for any reason, including prior enrolment in this trial.
- Severe comorbid illness with life expectancy less than 90 days, or likely to prevent completing 90-day follow-up.
- Long term care facility resident or prisoner 10) Participation in another clinical trial outside of the ACT-GLOBAL platform investigating a drug or medical device or a neuro-interventional or surgical procedure that is not considered as standard care in the 30 days preceding trial enrolment.
Where it is running
- University of Calgary - Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)
- University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
- University of Manitoba — Winnipeg, Manitoba, Canada (enrolling)
- Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
- Unity Health Toronto, St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
- Royal University Hospital — Saskatoon, Saskatchewan, Canada (enrolling)
Full record on ClinicalTrials.gov
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