NoNO-42 Trial in Acute Ischemic Stroke Patients Selected for Thrombolysis With or Without Endovascular Thrombectomy

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• University of Calgary - Foothills Medical Centre, Calgary, Alberta, Canada
• University of Alberta Hospital, Edmonton, Alberta, Canada
• Vancouver General Hospital, Vancouver, British Columbia, Canada
• University of Manitoba, Winnipeg, Manitoba, Canada
• Hamilton General Hospital, Hamilton, Ontario, Canada
• Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
• Unity Health Toronto, St. Michael's Hospital, Toronto, Ontario, Canada
• Royal University Hospital, Saskatoon, Saskatchewan, Canada

Who to contact

Michael Tymianski, MD PhD · 416-583-1687 · mtymianski@nonoinc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06403267.