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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  45 to 90

Participation Criteria

Inclusion Criteria:

1. Acute ischemic stroke (AIS) selected for thrombolysis with or without EVT.
2. Onset (last-known-well) time to randomization time within 3 hours.
3. Ages ≥ 45 to ≤ 90 years.
4. Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS) \> 5.
5. Confirmed 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, defined as early ischemic changes on NCCT.
2. Any intracranial hemorrhage on qualifying imaging.
3. Unlikely to initiate study drug/placebo administration before arterial puncture in those selected for EVT.
4. Estimated or known weight \> 115 kg (253 lbs).
5. Known/suspected pregnancy and/or lactation.
6. Systolic blood pressure \< 90 mmHg
7. 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 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.