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

RecruitingPhase 2Ages 18 Years - 90 YearsAllNoNO Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • NoNO-42
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Where

9 sites
University of Calgary - Foothills Medical Centre
Calgary, Canada
University of Alberta Hospital
Edmonton, Canada
Vancouver General Hospital
Vancouver, Canada
University of Manitoba
Winnipeg, Canada
Hamilton General Hospital
Hamilton, Canada
Ottawa Hospital Research Institute
Ottawa, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Unity Health Toronto, St. Michael's Hospital
Toronto, Canada

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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