CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN

Phase 3

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: carbogen with or without phenyleprhine; Drug: phenylephrine

• Registration Number: NCT06770426
• Lead Sponsor: Yonsei University

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Study Start: 2025-02
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥20 years
• Anterior circulation progressing stroke
• Neurological worsening either 1 point in NIHSS score or MRC grade

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbogen + phenylephrine group	carbogen with or without phenyleprhine	-
Phenylephrine group	phenylephrine	-

Primary Outcome Measures

Name	Time	Method
percent improvement of NIHSS score in each group	24 hours	(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
difference of NIHSS score in each group	24 hours	baseline NIHSS score-post-treatment NIHSS score
difference of MRC score in each group	difference of MRC score in each group	baseline MRC score-post-treatment MRC score
Saftety outcome: discontinuing patients	within 7 days	Number of discontinuing patients due to side effects
percent improvement of MRC score in each group	within 24 hours	(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
Saftety outcome: Side effect	within 7 days	Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)

Secondary Outcome Measures

Name	Time	Method
Comparision between groups by percent improvement of NIHSS score	24 hours	(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
Comparision between groups by difference of MRC score	within 24 hours	baseline MRC score-post-treatment MRC score
Functional independencec	3 months after onset	modifed Rankin score 0 to 2
Comparision between groups by differnece of NIHSS score	24 hours	baseline NIHSS score-post-treatment NIHSS score
Comparision between groups by percent improvement in MRC score	within 24 hours	(baseline MRC score-post-treatment MRC score)/baseline MRC score×100

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of