Acute Ischemic StrokePhase 3NCT06770426
CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN
A Phase 3 study testing carbogen with or without phenyleprhine and phenylephrine in people with Acute Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
Progressing stroke is associated poor functional outcome and neurological deficit. Currently, no treatment for progressing stroke is recommended on the guideline. Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- carbogen with or without phenyleprhine and phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20 years
- Anterior circulation progressing stroke
- Neurological worsening either 1 point in NIHSS score or MRC grade
Who cannot join
- Age under 20 years.
- Patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator.
- Patients with Moyamoya disease.
- Patients with severe cerebrovascular reactivity (CVR) impairment due to cerebral vascular stenosis, making study participation challenging as determined by the investigator.
- Patients unable to undergo CO2 treatment (e.g., panic disorder, anxiety disorders, or other psychiatric conditions).
- Patients with hypersensitivity to phenylephrine.
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- Patients with persistent bradycardia (heart rate < 50 bpm).
- Patients with a history of hemorrhagic stroke or at risk of cerebral hemorrhage.
- Patients with a pre-stroke modified Rankin Scale (mRS) score ≥ 2, indicating impaired functional independence.
- Patients ineligible for phenylephrine treatment due to any of the following:
- Myocardial infarction or unstable angina within the past 3 months. Cardiac ejection fraction < 25%. Ventricular arrhythmia. Systolic blood pressure > 200 mmHg. Serum creatinine > 2 mg/dL. Pregnancy.
- Use of monoamine oxidase (MAO) inhibitors.
- Patients who do not consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN(CARBOGEN Trial)
Progressing stroke is associated poor functional outcome and neurological deficit.
Currently, no treatment for progressing stroke is recommended on the guideline.
Read more
Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia.
CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow.
Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressing stroke.
Induced hypertension is alternative treatment of progressing stroke. Increasing blood pressure also induce cerebral blood flow. Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. Several studies reported that the effectiveness of phenylephrine on progressing stroke.
Therefore, this study will compare the effectiveness of carbogen + phenyleprhine versus phenlyephrine in progressing stroke patients.
- Conditions
- Acute Ischemic Stroke
- Being tested
- carbogen with or without phenyleprhine, phenylephrine
- Keywords
- CO2, carbogen, phenylephrine, lacunar infarction, progressing stroke
- Medical subject headings
- Ischemic Stroke, Stroke, Lacunar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbogen with or without phenyleprhineDrug
Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes. All patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.
phenylephrineDrug
All patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Carbogen + phenylephrine group | Experimental | Not described Receives: Drug: carbogen with or without phenyleprhine |
| Phenylephrine group | Active comparator | Not described Receives: Drug: phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent improvement of NIHSS score in each group
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
Measured: 24 hours
difference of NIHSS score in each group
baseline NIHSS score-post-treatment NIHSS score
Measured: 24 hours
percent improvement of MRC score in each group
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
Measured: within 24 hours
difference of MRC score in each group
baseline MRC score-post-treatment MRC score
Measured: difference of MRC score in each group
Saftety outcome: Side effect
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
Measured: within 7 days
Saftety outcome: discontinuing patients
Number of discontinuing patients due to side effects
Measured: within 7 days
Secondary outcomes (5)
Comparision between groups by percent improvement of NIHSS score
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
Measured: 24 hours
Comparision between groups by differnece of NIHSS score
baseline NIHSS score-post-treatment NIHSS score
Measured: 24 hours
Comparision between groups by percent improvement in MRC score
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
Measured: within 24 hours
Comparision between groups by difference of MRC score
baseline MRC score-post-treatment MRC score
Measured: within 24 hours
Functional independencec
modifed Rankin score 0 to 2
Measured: 3 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. The study is a single center, prospective, randomized, open-label trial with blinded end-point assessment (PROBE) design study. 2. For the patients with progressing stroke, the carbogen + phenylphrine group and the phenylephrine only group will be randomized by 1: 1 through web-based app. 3. Patients will be enrolled from February 2025 to September 2027 (based on the date of stroke). 4. We will collect medical history, laboratory findings, neurological scores, and functional recovery. 5. Functional recovery scores are performed by independent researchers in the blind state. 6. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication. 7. Central adjudication will review the image study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770426
- Sponsor's protocol ID
- 4-2024-1415
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN(CARBOGEN Trial)
- ClinicalTrials.gov ID
- NCT06770426
- Acronym / sponsor ID
- 4-2024-1415
- Conditions
- Acute Ischemic Stroke
- Keywords
- CO2, carbogen, phenylephrine, lacunar infarction, progressing stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Progressing stroke is associated poor functional outcome and neurological deficit.
Currently, no treatment for progressing stroke is recommended on the guideline.
Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia.
CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow.
Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressing stroke.
Induced hypertension is alternative treatment of progressing stroke. Increasing blood pressure also induce cerebral blood flow. Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. Several studies reported that the effectiveness of phenylephrine on progressing stroke.
Therefore, this study will compare the effectiveness of carbogen + phenyleprhine versus phenlyephrine in progressing stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1. The study is a single center, prospective, randomized, open-label trial with blinded end-point assessment (PROBE) design study. 2. For the patients with progressing stroke, the carbogen + phenylphrine group and the phenylephrine only group will be randomized by 1: 1 through web-based app. 3. Patients will be enrolled from February 2025 to September 2027 (based on the date of stroke). 4. We will collect medical history, laboratory findings, neurological scores, and functional recovery. 5. Functional recovery scores are performed by independent researchers in the blind state. 6. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication. 7. Central adjudication will review the image study.
| Arm | Type | Receives |
|---|---|---|
| Carbogen + phenylephrine group | Experimental | Drug: carbogen with or without phenyleprhine |
| Phenylephrine group | Active comparator | Drug: phenylephrine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥20 years
- Anterior circulation progressing stroke
- Neurological worsening either 1 point in NIHSS score or MRC grade
Key exclusion criteria (13 listed)
- Age under 20 years.
- Patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator.
- Patients with Moyamoya disease.
- Patients with severe cerebrovascular reactivity (CVR) impairment due to cerebral vascular stenosis, making study participation challenging as determined by the investigator.
- Patients unable to undergo CO2 treatment (e.g., panic disorder, anxiety disorders, or other psychiatric conditions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbogen with or without phenyleprhinePatients will inhale carbogen gas for 10 minutes and rest for 50 minutes. All patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg. | Drug | Carbogen + phenylephrine group |
| phenylephrineAll patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg. | Drug | Phenylephrine group |
Primary outcome
percent improvement of NIHSS score in each group
Time frame: 24 hours
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
difference of NIHSS score in each group
Time frame: 24 hours
baseline NIHSS score-post-treatment NIHSS score
percent improvement of MRC score in each group
Time frame: within 24 hours
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
difference of MRC score in each group
Time frame: difference of MRC score in each group
baseline MRC score-post-treatment MRC score
Saftety outcome: Side effect
Time frame: within 7 days
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
Saftety outcome: discontinuing patients
Time frame: within 7 days
Number of discontinuing patients due to side effects
5 secondary outcomes
Comparision between groups by percent improvement of NIHSS score
Time frame: 24 hours
Comparision between groups by differnece of NIHSS score
Time frame: 24 hours
Comparision between groups by percent improvement in MRC score
Time frame: within 24 hours
Comparision between groups by difference of MRC score
Time frame: within 24 hours
Functional independencec
Time frame: 3 months after onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carbogen with or without phenyleprhine and phenylephrine in people with Acute Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent improvement of NIHSS score in each group (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.