NCT06403267RecruitingPhase 2
NoNO-42 Trial in Acute Ischemic Stroke Patients Selected for Thrombolysis With or Without Endovascular Thrombectomy
A Multicentre, Prospective, Randomized, Open Label, Blinded-Endpoint, Placebo-controlled, Single-dose Trial to Determine the Efficacy and Safety of NoNO-42 in Participants With Acute Ischemic Stroke Selected for Thrombolysis With or Without Endovascular Thrombectomy (ACT-42 Trial)
Source: ClinicalTrials.gov · Last updated 15 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 26 Apr 2024
- Start date
- Oct 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- NoNO Inc.
- Diseases
- Stroke
- NCT number
- NCT06403267
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 600
- From Oct 2024 to the primary completion date, Dec 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unlikely to initiate study drug administration before arterial puncture in those selected for EVT.
- Known prior receipt of NoNO-42 for any reason, including prior enrolment in this trial.
- 8\) Severe comorbid illness with life expectancy less than 90 days, or likely to prevent completing 90-day follow-up.
- 9\) 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.
Other illness
- Any intracranial hemorrhage on qualifying imaging.
Other
- Large extent early ischemic changes/infarct in the ischemic territory on qualifying imaging.
- Known/suspected pregnancy and/or lactation.
- Systolic blood pressure \< 90 mmHg
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary- Foothills Medical Centre Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Hamilton General Hospital Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Ottawa Hospital Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Royal University Hospital Coordinator of this site? Confirm its status | Saskatoon | Canada | Recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Unity Health Toronto, St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| University of Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.