Acute Ischemic StrokePhase 3NCT04839224
Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)
A Phase 3 study testing carbogen and phenylephrine in people with Acute Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
Lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . Twenty percent of ischemic stroke is lacunar infarction. However, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening. 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 and phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2021to 12 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 progressive lacunar infarction.
- Neurological worsening either 1 point in NIHSS score or MRC grade
Who cannot join
- Age <20
- Cortical infarction
- Posterior circulation lacunar infarction
- Relevant artery stenosis more than 50% or occlusion
- Moyamoya disease
- Difficulty in inhalation of Carbogen (panic, severe anxiety disorder)
Show all 10Show fewer
- Drug allergy for phenylephrine
- Persistent bradycardia (pulse rate < 50 /min)
- History of hemorrhagic stroke
- Pre-stroke mRS ≥2
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . Twenty percent of ischemic stroke is lacunar infarction.
However, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening.
Read more
Progressive lacunar infarction is associated poor functional outcome and neurological deficit.
Currently, no treatment for progressive lacunar infarction is recommended on the guideline.
Several small study reported that phenylephrine and magnesium may be helpful for progressive lacunar infarction.
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.
Lacunar infarction is small and perfused with marginal flow by neighboring perforating arteriole.
Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressive lacunar infarction.
Induced hypertension is alternative treatment of progressive lacunar infarction. 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 versus phenylephrine in lacunar infarction patients who suffered neurological worsening.
- Conditions
- Acute Ischemic Stroke
- Being tested
- carbogen, phenylephrine
- Keywords
- CO2, carbogen, phenylephrine, lacunar infarction, progressive 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.
carbogenDrug
Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.
phenylephrineDrug
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 group | Experimental | Not described Receives: Drug: carbogen |
| 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: 48 hours
difference of NIHSS score in each group
baseline NIHSS score-post-treatment NIHSS score
Measured: 48 hours
percent improvement of MRC score in each group
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
Measured: within 48 hours
difference of MRC score in each group
baseline MRC score-post-treatment MRC score
Measured: within 48 hours
Safety outcome: Side effect
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
Measured: within 7 days
Safety outcome: discontinuing patients
Number of discontinuing patients due to side effects
Measured: within 7 days
Secondary outcomes (5)
Comparison between groups by percent improvement of NIHSS score
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
Measured: 48 hours
Comparison between groups by difference of NIHSS score
baseline NIHSS score-post-treatment NIHSS score
Measured: 48 hours
Comparison between groups by percent improvement in MRC score
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
Measured: within 48 hours
Comparison between groups by difference of MRC score
baseline MRC score-post-treatment MRC score
Measured: within 48 hours
Functional independence
modified Rankin score 0 to 2
Measured: upon discharge, 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 posted9 Apr 2021
- Study start5 Apr 2021
- Primary completion18 Oct 2022
- Study completion12 Sep 2024
Why it stopped: Slow Patient Enrollment
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 neurological worsening after lacunar infarction, the carbogen group and the phenylephrine group will be randomized by 1: 1. 3. Patients will be enrolled from April 2021 to December 2022 (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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyo Suk Nam, MD, PhD, Principal investigator, Department of Neurology, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839224
- Sponsor's protocol ID
- 4-2020-1491
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2021
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)
- ClinicalTrials.gov ID
- NCT04839224
- Acronym / sponsor ID
- 4-2020-1491
- Conditions
- Acute Ischemic Stroke
- Keywords
- CO2, carbogen, phenylephrine, lacunar infarction, progressive stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Patient Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 9 Apr 2021 (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.
Lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . Twenty percent of ischemic stroke is lacunar infarction.
However, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening.
Progressive lacunar infarction is associated poor functional outcome and neurological deficit.
Currently, no treatment for progressive lacunar infarction is recommended on the guideline.
Several small study reported that phenylephrine and magnesium may be helpful for progressive lacunar infarction.
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.
Lacunar infarction is small and perfused with marginal flow by neighboring perforating arteriole.
Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressive lacunar infarction.
Induced hypertension is alternative treatment of progressive lacunar infarction. 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 versus phenylephrine in lacunar infarction patients who suffered neurological worsening.
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 neurological worsening after lacunar infarction, the carbogen group and the phenylephrine group will be randomized by 1: 1. 3. Patients will be enrolled from April 2021 to December 2022 (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 group | Experimental | Drug: carbogen |
| 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 progressive lacunar infarction.
- Neurological worsening either 1 point in NIHSS score or MRC grade
Key exclusion criteria (10 listed)
- Age <20
- Cortical infarction
- Posterior circulation lacunar infarction
- Relevant artery stenosis more than 50% or occlusion
- Moyamoya disease
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 |
|---|---|---|
| carbogenPatients will inhale carbogen gas for 10 minutes and rest for 50 minutes. | Drug | Carbogen group |
| phenylephrineStart 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: 48 hours
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
difference of NIHSS score in each group
Time frame: 48 hours
baseline NIHSS score-post-treatment NIHSS score
percent improvement of MRC score in each group
Time frame: within 48 hours
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
difference of MRC score in each group
Time frame: within 48 hours
baseline MRC score-post-treatment MRC score
Safety outcome: Side effect
Time frame: within 7 days
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
Safety outcome: discontinuing patients
Time frame: within 7 days
Number of discontinuing patients due to side effects
5 secondary outcomes
Comparison between groups by percent improvement of NIHSS score
Time frame: 48 hours
Comparison between groups by difference of NIHSS score
Time frame: 48 hours
Comparison between groups by percent improvement in MRC score
Time frame: within 48 hours
Comparison between groups by difference of MRC score
Time frame: within 48 hours
Functional independence
Time frame: upon discharge, 3 months after onset
Results and safety
The study was stopped early (reason given: Slow Patient Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hyo Suk Nam, MD, PhD principal investigator
Department of Neurology, Yonsei University College of Medicine
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 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 10 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: stopped early, as of the sponsor's last update on 14 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?
The study was stopped early (reason given: Slow Patient Enrollment). Results are not available in the source record.
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: 48 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 14 Jan 2025.