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Could a simple gas help stroke patients? early trial launches

NCT ID NCT05871606

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

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