StrokePhase 2/3PRO-CHASENCT05419193
PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)
A Phase 2/3 study testing Propranolol Hydrochloride in people with Stroke and Vascular Accident, run by Beijing Tiantan Hospital at 12 sites in China.
Trial summary
Stroke-associated pneumonia (SAP) is a grave complication of stroke and one of the most important predictors for patients' poor outcomes. Stroke associated pneumoniaSAP and other infections limited the overall efficacy of stroke management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Vascular Accident, Intracranial Hemorrhages
- What is being tested?
- Propranolol Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 12 sitesChina
- Study dates
- 21 Feb 2023to 11 Mar 2025
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years older and less than 80 years.
- Onset of new neurological deficits within≤24 hours at the time of randomization
- CT scan demonstrates supratentorial parenchymal hemorrhage and volume of hematoma≥10ml .
- Initial NIHSS score of 11 or greater and less than 25 scores.
- Initial GCS score (aggregate of verbal, eye, and motor response scores) of 8 or greater at time of enrollment.
- Admission without infection signs.
- Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
Who cannot join
- Subjects is considered a candidate for immediate surgical intervention by the neurosurgery service, including surgical evacuation of hematoma, decompressive craniectomy, minimally invasive aspiration of hematoma, and ventricular shunt or external ventricular drainage for intracerebral hemorrhage into the ventricle.
- Patients with primary intraventricular hemorrhage or cerebral hemorrhage due to a definite cause, such as trauma, vascular malformation, aneurysm, coagulopathy, anticoagulant or antiplatelet drugs, thrombolytic therapy, post-infarction hemorrhagic transformation, hematologic disease, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, vasculitis, etc.
- Previous stroke or pre-onset motor disability (mRS≥1)
- Pregnancy or parturition within previous 30 days or active lactation.
- Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, etc.) or reserpine within the last 30 days.
- Bronchial asthma or chronic obstructive pulmonary disease
Show all 13Show fewer
- Cardiogenic shock or severe or acute heart failure.
- Degree II-III atrioventricular block or sinus bradycardia or heart rate ≤65/min.
- Known sensitivity to propranolol.
- Severe hepatic or renal insufficiency
- History of Malignancy
- Currently participating in other interventional clinical trials.
- Immunosuppressant therapy or known immunosuppression.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100070
Third Affiliated Hospital, Soochow University
Changzhou, Jiangsu, 213003
Lu'an Hospital of Traditional Chinese Medicine
Lu'an, Anhui
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality
The 970th Hospital of the Chinese People's Liberation Army (Weihai Branch)
Weihai, Shandong
Weinan City Center hospital
Weinan, Shaanxi
Tangdu Hospital,Air Force Medical University
Xi'an, Shaanxi
Xi'an Central Hospital
Xi'an, Shaanxi
Qianxian People's Hospital
Xianyang, Shaanxi
The First People' Hospital of Xian Yang
Xianyang, Shaanxi
Xianyang hospital affliated of Yan'an University
Xianyang, Shaanxi
The 970th Hospital of the Chinese People's Liberation Army (Yantai Branch)
Yantai, Shandong
About this study
Official title: Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia
Stroke-associated pneumonia (SAP) is a grave complication of stroke and one of the most important predictors for patients' poor outcomes. Stroke associated pneumoniaSAP and other infections limited the overall efficacy of stroke management. Increasing evidence suggests that sympathetic nervous system activity contributes to post post-stroke immunosuppression and emergence of infections. This study is designed to test the safety and efficacy of an adrenergic β receptor blocker propranolol in reducing SAP in hemorrhagic stroke patients, in a multi-center, randomized, open-labeled, end point-blinded, trial.
Read the detailed description
This study will enroll 168 intracerebral hemorrhage patients who meet the inclusion criteria.
ICH patients meet the inclusion criteria will be randomly assigned at a 1:1 ratio into groups of standard treatment (blank-controlled), or propranolol hydrochloride injection .
Patients allocated to experimented group will be intravenously given initial dose at 5mg propranolol hydrochloride daily over a course of 7 consecutive days, The primary purpose of this study is to compare propranolol hydrochloride with standard treatment on reducing the 7-day risk of pneumonia when initiated within 24 hours of symptom onset in intracerebral hemorrhage.
Both intent analysis (ITT) and per-protocol (PP) were used for analysis.
- Conditions
- Stroke, Vascular Accident, Intracranial Hemorrhages, Intracerebral Hemorrhage, Hemorrhagic Stroke, Stroke, Acute
- Being tested
- Propranolol Hydrochloride, control group
- Keywords
- Stroke, propranolol, infection, treatment
- Medical subject headings
- Stroke, Intracranial Hemorrhages, Cerebral Hemorrhage, Hemorrhagic Stroke, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Day of randomization:
propranolol IV vp for 7 days after randomization
control groupOther
Patients will receive usual care and drug use in hospital
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients will receive usual care and drug use in hospital. Receives: Other: control group |
| Propranolol group | Experimental | Propranolol hydrochloride will be administered intravenously via pump at a initial dose of 5mg/day over a course of 7 consecutive days after randomization. Receives: Drug: Propranolol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke-associated pneumonia
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
Measured: up to 7days
Secondary outcomes (4)
Clinical improvement
Modified Rankin Scale （mRS，0-6 scores, poor outcome defined as mRS≥4）are used to describe the clinical improvement at baseline, 7days, 14days, 30days and 90days.
Measured: up to 90 days
Change in immunology function [ Time Frame: up to 7 days ]（ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation）
Use the flow cytometry to measure the change of ratio and number of CD4+、CD8+、NK 、B cells at baseline, 3 days, 7 days
Measured: up to 7 days
Spleen volume [ Time Frame: up to 7 days ] （ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation）
Spleen volume calculated based on Abdominal CT.
Measured: up to 7 days
Adverse Event (AE)
Per protocol Adverse Event (AE), Adverse Reaction (AR), Serious Adverse Event / Reaction (SAE / SAR), and Suspected Unexpected Serious Adverse Reactions (SUSAR)
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start21 Feb 2023
- Primary completion18 Dec 2024
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu-Dong Shi, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419193
- Sponsor's protocol ID
- KY-2022-05-07-001
- Acronym
- PRO-CHASE
- Status last verified
- Mar 2025
- First submitted
- 2 Jun 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol,statistical analysis plan(SAP),informed consent form(ICF),clinical study report(CSR),analytic code will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia
- ClinicalTrials.gov ID
- NCT05419193
- Acronym / sponsor ID
- PRO-CHASE / KY-2022-05-07-001
- Conditions
- Stroke, Vascular Accident, Intracranial Hemorrhages, Intracerebral Hemorrhage, Hemorrhagic Stroke, Stroke, Acute
- Keywords
- Stroke, propranolol, infection, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 15 Jun 2022 (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.
Stroke-associated pneumonia (SAP) is a grave complication of stroke and one of the most important predictors for patients' poor outcomes. Stroke associated pneumoniaSAP and other infections limited the overall efficacy of stroke management. Increasing evidence suggests that sympathetic nervous system activity contributes to post post-stroke immunosuppression and emergence of infections. This study is designed to test the safety and efficacy of an adrenergic β receptor blocker propranolol in reducing SAP in hemorrhagic stroke patients, in a multi-center, randomized, open-labeled, end point-blinded, trial.
Detailed description
This study will enroll 168 intracerebral hemorrhage patients who meet the inclusion criteria.
ICH patients meet the inclusion criteria will be randomly assigned at a 1:1 ratio into groups of standard treatment (blank-controlled), or propranolol hydrochloride injection .
Patients allocated to experimented group will be intravenously given initial dose at 5mg propranolol hydrochloride daily over a course of 7 consecutive days, The primary purpose of this study is to compare propranolol hydrochloride with standard treatment on reducing the 7-day risk of pneumonia when initiated within 24 hours of symptom onset in intracerebral hemorrhage.
Both intent analysis (ITT) and per-protocol (PP) were used for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: control groupPatients will receive usual care and drug use in hospital. |
| Propranolol group | Experimental | Drug: Propranolol HydrochloridePropranolol hydrochloride will be administered intravenously via pump at a initial dose of 5mg/day over a course of 7 consecutive days after randomization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years older and less than 80 years.
- Onset of new neurological deficits within≤24 hours at the time of randomization
- CT scan demonstrates supratentorial parenchymal hemorrhage and volume of hematoma≥10ml .
- Initial NIHSS score of 11 or greater and less than 25 scores.
- Initial GCS score (aggregate of verbal, eye, and motor response scores) of 8 or greater at time of enrollment.
Key exclusion criteria (13 listed)
- Subjects is considered a candidate for immediate surgical intervention by the neurosurgery service, including surgical evacuation of hematoma, decompressive craniectomy, minimally invasive aspiration of hematoma, and ventricular shunt or external ventricular drainage for intracerebral hemorrhage into the ventricle.
- Patients with primary intraventricular hemorrhage or cerebral hemorrhage due to a definite cause, such as trauma, vascular malformation, aneurysm, coagulopathy, anticoagulant or antiplatelet drugs, thrombolytic therapy, post-infarction hemorrhagic transformation, hematologic disease, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, vasculitis, etc.
- Previous stroke or pre-onset motor disability (mRS≥1)
- Pregnancy or parturition within previous 30 days or active lactation.
- Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, etc.) or reserpine within the last 30 days.
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 |
|---|---|---|
| Propranolol HydrochlorideDay of randomization: propranolol IV vp for 7 days after randomization | Drug | Propranolol group |
| control groupPatients will receive usual care and drug use in hospital | Other | Control group |
Primary outcome
Incidence of stroke-associated pneumonia
Time frame: up to 7days
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
4 secondary outcomes
Clinical improvement
Time frame: up to 90 days
Change in immunology function [ Time Frame: up to 7 days ]（ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation）
Time frame: up to 7 days
Spleen volume [ Time Frame: up to 7 days ] （ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation）
Time frame: up to 7 days
Adverse Event (AE)
Time frame: up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Yes. The study protocol,statistical analysis plan(SAP),informed consent form(ICF),clinical study report(CSR),analytic code will be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propranolol Hydrochloride in people with Stroke and Vascular Accident, run by Beijing Tiantan Hospital at 12 sites in China.
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 7 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: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of stroke-associated pneumonia (time frame: up to 7days). 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 Jul 2025.