NCT06403267 NoNO-42 Trial in Acute Ischemic Stroke Patients Selected for Thrombolysis With or Without Endovascular Thrombectomy
| NCT ID | NCT06403267 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | NoNO Inc. |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 600 participants in total. It began in 2024-10-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Confirmed or suspected acute ischemic stroke (AIS) selected for intravenous thrombolysis. 2. Onset (last-known-well) time to randomization time within 4.5 hours. 3. Ages ≥ 18 to ≤ 90 years. 4. Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS) \>5. 5. Confirmed or suspected symptomatic anterior circulation intracranial occlusion. Tandem extracranial carotid and intracranial occlusions are permitted. 6. Pre-stroke independent functional status in activities of daily living as judged by the enrolling physician. Patient must be living without requiring nursing care. 7. Consent process completed as per national laws and regulation and the applicable ethics committee requirements. Exclusion Criteria: 1. Large extent early ischemic changes/infarct in the ischemic territory on qualifying imaging. 2. Any intracranial hemorrhage on qualifying imaging. 3. Unlikely to initiate study drug administration before arterial puncture in those selected for EVT. 4. Known/suspected pregnancy and/or lactation. 5. Systolic blood pressure \< 90 mmHg 6. 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.
Contact & Investigator
Bijoy Menon, MBBS, MD
STUDY CHAIR
University of Calgary
Frequently Asked Questions
Who can join the NCT06403267 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06403267 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06403267 currently recruiting?
Yes, NCT06403267 is actively recruiting participants. Contact the research team at mtymianski@nonoinc.ca for enrollment information.
Where is the NCT06403267 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Vancouver, Canada, Winnipeg, Canada and 5 additional locations.
Who is sponsoring the NCT06403267 clinical trial?
NCT06403267 is sponsored by NoNO Inc.. The principal investigator is Bijoy Menon, MBBS, MD at University of Calgary. The trial plans to enroll 600 participants.
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