Actively Recruiting

Phase 2
Age: 18Years - 90Years
All Genders
NCT06403267

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

Led by NoNO Inc. · Updated on 2025-07-15

600

Participants Needed

9

Research Sites

112 weeks

Total Duration

On this page

Sponsors

N

NoNO Inc.

Lead Sponsor

U

University of Calgary

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed or suspected acute ischemic stroke selected for intravenous thrombolysis.
  • Stroke onset (last-known-well) to randomization within 4.5 hours.
  • Age between 18 and 90 years.
  • Disabling stroke with baseline NIH Stroke Score greater than 5.
  • Confirmed or suspected symptomatic anterior circulation intracranial occlusion, including tandem extracranial carotid and intracranial occlusions.
  • Independent in daily activities before stroke as judged by the enrolling physician; not requiring nursing care.
  • Consent obtained according to national laws and ethics committee requirements.
Not Eligible

You will not qualify if you...

  • Large extent early ischemic changes or infarct in the affected brain area on imaging.
  • Any intracranial hemorrhage seen on qualifying imaging.
  • Unlikely to receive study drug before arterial puncture if selected for endovascular thrombectomy.
  • Known or suspected pregnancy or lactation.
  • Systolic blood pressure below 90 mmHg.
  • Previous receipt of NoNO-42, including prior participation in this trial.
  • Severe other illness with life expectancy under 90 days or likely to prevent completing 90-day follow-up.
  • Resident in long term care facility or prisoner.
  • Participation in another clinical trial involving drugs, devices, neuro-interventions, or surgery not considered standard care within 30 days before enrollment.

AI-Screening

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Trial Site Locations

Total: 9 locations

1

University of Calgary - Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

2

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

3

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5M 1Z9

Actively Recruiting

4

University of Manitoba

Winnipeg, Manitoba, Canada, R3E 3P5

Actively Recruiting

5

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

6

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

7

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

8

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

9

Royal University Hospital

Saskatoon, Saskatchewan, Canada, S7N 0W8

Actively Recruiting

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Research Team

M

Michael Tymianski, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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