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

Launched by NONO INC. · May 6, 2024

Keywords

ClinConnect Summary

The NoNO-42 Trial is a research study focused on patients who have experienced an acute ischemic stroke, a condition where blood flow to the brain is blocked. This trial aims to evaluate the safety and effectiveness of a treatment given to patients who are eligible for a specific type of therapy called thrombolysis, which helps dissolve blood clots. Participants in this study will be adults aged between 45 and 90 years old, who have suffered a disabling stroke and can begin treatment within 3 hours of when they were last known to be well. To take part, they must also be able to perform daily activities independently before the stroke occurred.

Those who join the trial can expect to receive either the study treatment or a placebo (a substance with no active effect) and will be monitored closely for 90 days to assess their recovery. It's important to note that there are certain criteria that would exclude someone from participating, such as having significant health issues or being pregnant. This trial is currently recruiting participants, and the goal is to better understand how this treatment might help improve outcomes for stroke patients.

Gender

ALL

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.