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

Last updated: July 10, 2025
Sponsor: NoNO Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Thrombosis

Blood Clots

Stroke

Treatment

Placebo

NoNO-42

Clinical Study ID

NCT06403267
NoNO42-02 (ACT-42)
  • Ages 18-90
  • All Genders

Study 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

Inclusion Criteria:

  1. Confirmed or suspected acute ischemic stroke (AIS) selected for intravenousthrombolysis.

  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 bythe enrolling physician. Patient must be living without requiring nursing care.

  7. Consent process completed as per national laws and regulation and the applicableethics committee requirements.

Exclusion

Exclusion Criteria:

  1. Large extent early ischemic changes/infarct in the ischemic territory on qualifyingimaging.

  2. Any intracranial hemorrhage on qualifying imaging.

  3. Unlikely to initiate study drug administration before arterial puncture in thoseselected 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 thistrial.

  1. Severe comorbid illness with life expectancy less than 90 days, or likely to preventcompleting 90-day follow-up.

  2. Long term care facility resident or prisoner 10) Participation in another clinicaltrial outside of the ACT-GLOBAL platform investigating a drug or medical device or aneuro-interventional or surgical procedure that is not considered as standard carein the 30 days preceding trial enrolment.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 02, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Because AIS is a medical emergency, the trial is designed to enable the administration of standard-of-care treatments in order to save the life of the person concerned, restore good health and alleviate suffering.

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. Randomization will be 1:1 drug/placebo. Randomization will be stratified by large vessel occlusion (LVO) (yes/no) and a minimization algorithm to minimize the contribution of imbalances in baseline factors (age, sex, baseline NIHSS score). The design is adaptive with prospective rules for adaptive enrichment, in which enrollment may be restricted to participants without an LVO. LVO is defined as an occlusion of the intracranial ICA, M1 or proximal M2.

Randomized participants will receive/received an intravenous thrombolytic and be allocated to:

  • the investigational group, a single, 2.6 mg/kg (up to a maximum of 300 mg) 20-minute intravenous dose of NoNO-42, with a target start time of less than 10 minutes from randomization or

  • the control group, no trial specific intervention.

Day 90: All participants will be followed for 90 days (or until death if prior to 90 days) for efficacy and 30 days for safety. The end of the trial is defined as the date that all participants have completed their Day 90 contact.

1-Year follow Up: participants who completed the trial to Day 90 may be followed at 1 year for long-term efficacy.

One database lock and corresponding report for the trial to Day 90 and a separate database lock and analysis for the 1-year follow up are planned.

Connect with a study center

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia V5M 1Z9
    Canada

    Active - Recruiting

  • University of Manitoba

    Winnipeg, Manitoba R3E 3P5
    Canada

    Active - Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Unity Health Toronto, St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Royal University Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Active - Recruiting

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