Treatment for Acute Ischemic Stroke Patients with Thrombolysis

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)

This study is testing if a new drug called NoNO-42 can help people aged 45 to 90 who are having an acute ischemic stroke and are getting thrombolysis treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: NoNO Inc. (industry)
• Locations: 9 sites (Calgary, Alberta and 8 other locations)
• Trial ID: NCT06403267 on ClinicalTrials.gov

What this trial studies

This Phase 2b trial investigates the efficacy of NoNO-42 in patients experiencing acute ischemic stroke who are eligible for thrombolysis with or without endovascular thrombectomy. The study will enroll up to 600 participants aged 45 to 90 years within 3 hours of stroke onset, using a randomized, controlled design with a 1:1 allocation to either NoNO-42 or placebo. Participants will receive a single intravenous dose of the study drug or placebo, and outcomes will be assessed over a 90-day follow-up period. The trial aims to evaluate both the efficacy and safety of the treatment in this critical patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 to 90 years with acute ischemic stroke eligible for thrombolysis within 3 hours of symptom onset.

Not a fit: Patients with large extent early ischemic changes or any intracranial hemorrhage will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Other studies have shown promise in similar approaches, but this specific treatment is being evaluated in a novel context.

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.

Where this trial is running

Calgary, Alberta and 8 other locations

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

Study contacts

• Study coordinator: Michael Tymianski, MD PhD

Conditions: Acute Ischemic Stroke, Thrombolysis, Endovascular thrombectomy, Reperfusion, Neuroprotection, Neuroprotectant