RESCUE: Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy
Study Details
Study Description
Brief Summary
A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 60 mL/h), 1 mL/kg/h RNS60 (up to a maximum of 120 mL/h), or 1 mL/kg/h (up to a maximum of 120 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study is a Phase II, randomized, blinded, placebo-controlled, parallel group design. Participants experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 60 mL/h), 1 mL/kg/h RNS60 (up to a maximum of 120 mL/h), or 1 mL/kg/h (up to a maximum of 120 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy and prior to arterial closure. Outcomes of the main trial will be evaluated throughout a 90 day observation period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RNS60 0.5 mL/kg/h RNS60 0.5 mL/kg/h infusion for 48h (up to a maximum of 60 mL/kg) starting within 30 min of randomization (but prior to arterial access closure) |
Drug: RNS60
RNS60 injection solution
|
| Experimental: RNS60 1 mL/kg/h RNS60 1 mL/kg/h infusion for 48h (up to a maximum of 120 mL/kg) starting within 30 min of randomization (but prior to arterial access closure) |
Drug: RNS60
RNS60 injection solution
|
| Placebo Comparator: Placebo 1 mL/kg/h Placebo (normal saline) 1 mL/kg/h infusion for 48h (up to a maximum of 120 mL/kg) starting within 30 min of randomization (but prior to arterial access closure) |
Drug: Placebo
Placebo injection solution
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with serious adverse events [90 days]
- Mortality: proportion of participants alive [90 days]
Secondary Outcome Measures
- Mean mRS score [90 days]
mRS = Modified Rankin Scale
- Reduction in mortality rate [90 days]
Lower event rate on the Kaplan Meier survival curve
- Mean NIHSS score [90 days]
NIHSS = National Institutes of Health Stroke Scale
- Proportion of participants with a worsening of stroke [90 days]
Worsening of stroke defined as progression, or hemorrhagic transformation, of the index stroke as documented by medical imaging and that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥4 point increase from lowest NIHSS during hospitalization and/or (c) results in death
- Mean BI [90 days]
Mean Barthel Index (BI) at Day 90 relative to pre-stroke BI
Other Outcome Measures
- Infarct progression/regression [90 days]
Infarct size measured by MRI brain imaging
- Quality of life score [90 days]
Health-related quality of life as measured by the 5-level EuroQoL 5D index (EQ-5D-5L)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
-
Age 18 years or older.
-
Onset (last-known-well) time to randomization time within 24 hours.
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Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
-
NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or
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NIHSS > 10 for M2-MCA occlusion.
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Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
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Pre-stroke (24 hours prior to stroke onset) historical modified Rankin Scale (mRS) ≤2. Patient must be living without requiring nursing care.
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Qualifying imaging performed less than 2 hours prior to randomization.
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Consent process completed as per applicable laws and regulation and the IRB requirements.
Exclusion Criteria:
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Evidence of a large core of established infarction defined as ASPECTS 0-4.
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Evidence of absence of collateral circulation on qualifying imaging (Collateral score of 0 or 1).
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Any evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.
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Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.
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Endovascular thrombectomy procedure is completed as defined by the presence of arterial access closure.
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Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
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Estimated or known weight > 130 kg (287 lbs).
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Known pregnant/lactating female.
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Myocardial infarction within 6 months prior to Screening including non-Q wave MI;
Diagnosis of CHF with either:
-
current clincial signs and symptoms of ventricular dysfunction (e.g., edema, shortness of breath),
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CHF medication adjustment within the prior 30 days or
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ejection fraction (if report available) of 30% or less measured in the 6 months prior to Screening; as either medically documented or reported by patient or another person considered by the Investigator to be reasonably reliable.
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Known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).
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Inability to have MRI imaging (Non- MR compatible implants or any other foreseeable reason, including claustrophobia)
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Severe or fatal comorbid illness that will prevent improvement or follow up.
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Inability to complete follow-up treatment to Day 90.
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Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.
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Reported known seizure at time of stroke onset.
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Ischemic stroke within previous 30 days.
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Patients in normal sinus rhythm with a known QTcF > 450 ms at Screening.
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Any other symptom that in the investigator's opinion may complicate or preclude the subject from participating in this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 2 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
Sponsors and Collaborators
- Revalesio Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06.5.1.H1