Treatment for Acute Ischemic Stroke Patients with Thrombolysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Michael Tymianski, MD PhD
• Email: mtymianski@nonoinc.ca
• Phone: 416-583-1687

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-Term outside-in nerve stimulation for acute ischemic stroke

  This trial tests whether a 5-day external trigeminal nerve stimulation given after stroke can help more patients recover better than a sham treatment.

  Recruiting Xidian University · Xi'an · NCT07911605

• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

• Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

  This study tests whether adding NRICM301, a traditional Chinese medicine formula, to usual care is safe for adults with acute ischemic stroke.

  Recruiting En Chu Kong Hospital · New Taipei City · NCT07900503

• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.