Could a simple gas help stroke patients? early trial launches
NCT ID NCT05871606
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether inhaled nitric oxide is safe for people having emergency clot removal after a stroke. It includes 36 adults with severe strokes. The main goal is to find the highest safe dose without causing brain bleeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inhaled nitric oxide (iNO)
- What this could lead to
- If safe, this could point toward a new way to protect the brain during stroke treatment.
- What could go wrong
- This is a very early phase 1 safety trial with only 36 people. It may not show benefit, and there is a risk of bleeding in the brain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 and \< 80 * Clinical evidence of acute ischemic (non-bleeding) stroke (AIS) with NIH Stroke Scale of 6 or higher * Non-contrast Computed tomography (CT) Head with ASPECT (Alberta Stroke Program Early CT) score 6 * Symptom onset began \< 16 hours from initiation of intra-arterial mechanical thrombectomy (IAMT) procedure * CT Angiogram (CTA) evidence of anterior circulation MCA (Middle Cerebral Artery) M1 or dominant proximal M2 segment occlusion. * CT Perfusion (CTP) evidence of core infarct volume of \< 70ml and a ratio of ischemic tissue to initial core infarct volume of 1.8 or greater, and an absolute volume of penumbra of 15ml or greater * Patient or patient's representative provides consent * Pre-stroke modified Rankin Scale (mRS) of \< =2 * General endotracheal anesthesia (GETA) is planned to be used, as standard care, for IAMT * Treatment with iNO requires mechanical ventilation. Because IAMT can be performed using conscious sedation and not GETA, only those patients for which the procedure is planned with GETA will be included. The decision for the type of anesthetic depends on the severity of stroke, region of brain affected by the stroke, and the ability for the patient to cooperate for the procedure. Exclusion Criteria: * Hypotension at presentation, defined as systolic blood pressure (SBP) \< 100 or MAP \< 60; profound hypertension with SBP \>185 or DBP \>110mmHg unable to be controlled with IV medications * Inability to undergo a brain MRI (e.g., implanted pacemaker) * Patients who received IV tPA \>4.5hrs after symptom onset * Coaguloapathy, defined as platelet count \< 50,000, INR \>3.0, PTT \> 3x normal, use of novel anticoagulants with eGFR \< 30ml/min * Vulnerable Subjects including: mentally ill or incompetent patients, those with diminished decision-making capacity, prisoners, inpatient care for long-term chronic illness, terminally ill, pregnant women, and children * Any form of hemorrhage on non-contrast CT Head or mass lesion * Severe head injury within 90 days * Pre-existing severe neurological/psychiatric disease * Seizure at stroke onset (unable to assess NIHSS) * Blood glucose \< 50mg/dL or \>400mg/dL * Hemoglobin \<7mmol/L * eGFR \< 30ml/min * Allergy to contrast media * Presumed septic embolus as source of stroke * Flow limiting intracranial or extracranial carotid stenosis, or complete carotid occlusion
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute cerebrovascular disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Atrium Health
RECRUITINGCharlotte, North Carolina, 28204, United States
-
Carolinas Medical Center
RECRUITINGCharlotte, North Carolina, 28203, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better