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Vasodilator
Inhaled Nitric Oxide for Ischemic Stroke (iNO Trial)
Phase 1
Waitlist Available
Led By William R Stetler, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical evidence of acute ischemic (non-bleeding) stroke (AIS) with NIH Stroke Scale of 6 or higher
Symptom onset began < 16 hours from initiation of intra-arterial mechanical thrombectomy (IAMT) procedure
Must not have
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
Flow limiting intracranial or extracranial carotid stenosis, or complete carotid occlusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if inhaling nitric oxide can help treat stroke caused by a blood clot in an artery.
Who is the study for?
This trial is for adults aged 18-79 who've had a recent ischemic stroke and are undergoing mechanical thrombectomy. They should have had mild to moderate disability before the stroke, show significant symptoms, and be within 16 hours of symptom onset. Patients with severe kidney issues, allergies to contrast media, extreme blood sugar levels or certain other health conditions are excluded.
What is being tested?
The study tests the safety and effectiveness of inhaled nitric oxide (iNO) in patients having a procedure called intra-arterial mechanical thrombectomy to remove blood clots caused by an acute ischemic stroke. Participants must require general anesthesia during this procedure.
What are the potential side effects?
While specific side effects of iNO in this context aren't detailed here, generally iNO can cause headaches, low blood pressure, methemoglobinemia (a condition where oxygen delivery is affected), or airway inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a stroke that wasn't caused by bleeding and my condition is serious.
Select...
My stroke symptoms started less than 16 hours before my clot removal procedure.
Select...
I was mostly independent before my stroke.
Select...
I am between 18 and 79 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not in a vulnerable group such as being mentally ill, a prisoner, terminally ill, pregnant, or a child.
Select...
I have a blockage in my brain or neck arteries.
Select...
I received IV tPA treatment more than 4.5 hours after my symptoms started.
Select...
I do not have severe blood clotting issues or use certain blood thinners with poor kidney function.
Select...
My blood pressure is either very low (<100/60) or very high (>185/110) and hard to control.
Select...
My stroke is thought to be caused by an infection in my blood.
Select...
My kidney function is severely reduced.
Select...
I had a seizure when my stroke started, making it hard to assess my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum safe dose of iNO for AIS patients - assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH)
Secondary study objectives
Change in pre-endovascular mechanical thrombectomy (IAMT) and post-IAMT core infarct volume
Side effects data
From 2021 Phase 4 trial • 519 Patients • NCT0308105228%
Venous Thromboemolic DVT
13%
Venous Thromboembolic Other
11%
New Onset Atrial Fibrillation
9%
All Cause Mortality
6%
Arterial Thromboembolic CVA/Stroke
5%
Venous Thromboembolic PE
3%
Arterial Thromboembolic Mesenteric Ischemia
2%
Arterial Thromboembolic Myocardial Infarction
2%
Upper GI Bleed
1%
Lower GI Bleed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lung Transplant With iNO
Lung Transplant With iEPO
Heart Transplant & LVAD Implantation With iNO
Heart Transplant & LVAD Implantation With iEPO
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Dose 5 GroupExperimental Treatment1 Intervention
Dose 5- Inhaled Nitrous Oxide (iNO) 80ppm.
Group II: Dose 4 GroupExperimental Treatment1 Intervention
Dose 4- Inhaled Nitrous Oxide (iNO) 70ppm.
Group III: Dose 3 GroupExperimental Treatment1 Intervention
Dose 3- Inhaled Nitrous Oxide (iNO) 60ppm.
Group IV: Dose 2 GroupExperimental Treatment1 Intervention
Dose 2- Inhaled Nitrous Oxide (iNO) 50ppm.
Group V: Dose 1 GroupExperimental Treatment1 Intervention
Dose 1- Inhaled Nitrous Oxide (iNO) 40ppm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iNO
2011
Completed Phase 4
~1370
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,460,009 Total Patients Enrolled
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,839 Total Patients Enrolled
William R Stetler, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke that wasn't caused by bleeding and my condition is serious.You have had a CT scan of your head without contrast, and the ASPECT score is 6 or lower.I am not in a vulnerable group such as being mentally ill, a prisoner, terminally ill, pregnant, or a child.I have a blockage in my brain or neck arteries.My stroke symptoms started less than 16 hours before my clot removal procedure.I received IV tPA treatment more than 4.5 hours after my symptoms started.I do not have severe blood clotting issues or use certain blood thinners with poor kidney function.You have any bleeding or abnormal growth in your head.I will be under general anesthesia for my throat surgery.You have a blockage in the main artery of the front part of your brain, as shown by a special type of x-ray called a CT Angiogram.The CT scan shows that the size of the damaged area in the brain is less than 70ml, and the ratio of the area at risk to the damaged area is 1.8 or higher, with at least 15ml of at-risk tissue.My blood pressure is either very low (<100/60) or very high (>185/110) and hard to control.My stroke is thought to be caused by an infection in my blood.I need a machine to help me breathe and will be asleep during my treatment due to the severity of my stroke.You are allergic to the dye used for imaging tests.My kidney function is severely reduced.I was mostly independent before my stroke.Your blood sugar levels are either too low (less than 50mg/dL) or too high (more than 400mg/dL).Your hemoglobin level is less than 7 mmol/L.I am between 18 and 79 years old.I had a seizure when my stroke started, making it hard to assess my condition.I have not had a severe head injury in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Dose 2 Group
- Group 2: Dose 1 Group
- Group 3: Dose 5 Group
- Group 4: Dose 4 Group
- Group 5: Dose 3 Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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