Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2
Awards & highlights
iNO Trial 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.Check my eligibility
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.See study design
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.
iNO Trial 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.
iNO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum safe dose of iNO for AIS patients - assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH)
Secondary outcome measures
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
iNO 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
1,239 Previous Clinical Trials
1,004,156 Total Patients Enrolled
13 Trials studying Stroke
13,197 Patients Enrolled for Stroke
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,201 Total Patients Enrolled
1 Trials studying Stroke
40 Patients Enrolled for Stroke
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration given its stamp of approval to Dose 1 Group?
"As it is a Phase 1 clinical trial, there remains limited evidence of Dose 1 Group's safety and efficacy; thus our team has assigned this drug candidate an initial rating of one."
Answered by AI
Might I be eligible to join this clinical exploration?
"This research study seeks to enrol 27 individuals who have suffered stroke and are within the age range of 18-80."
Answered by AI
Are elderly participants welcome to participate in the research endeavor?
"This clinical trial can only accept participants between the ages of 18 and 80. However, there are 6 studies specifically targeting those under 18 as well as 378 for individuals above 65 years old."
Answered by AI
Are there presently any openings for this research endeavor?
"This therapeutic trial is not accepting participants, according to information on clinicaltrials.gov which was last modified in May of 2023. Nevertheless, there are 387 alternative studies that currently have open enrolment for patients."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger