PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)
PRO-CHASE
Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia
1 other identifier
interventional
168
1 country
12
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Feb 2023
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedStudy Start
First participant enrolled
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2025
CompletedJuly 14, 2025
March 1, 2025
1.8 years
June 2, 2022
July 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of stroke-associated pneumonia
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
up to 7days
Secondary Outcomes (4)
Clinical improvement
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）
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）
up to 7 days
Adverse Event (AE)
up to 90 days
Study Arms (2)
Control group
PLACEBO COMPARATORPatients will receive usual care and drug use in hospital.
Propranolol group
EXPERIMENTALPropranolol hydrochloride will be administered intravenously via pump at a initial dose of 5mg/day over a course of 7 consecutive days after randomization.
Interventions
Day of randomization: propranolol IV vp for 7 days after randomization
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Lu'an Hospital of Traditional Chinese Medicine
Lu'an, Anhui, China
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100070, China
Third Affiliated Hospital, Soochow University
Changzhou, Jiangsu, 213003, China
Weinan City Center hospital
Weinan, Shaanxi, China
Tangdu Hospital,Air Force Medical University
Xi'an, Shaanxi, China
Xi'an Central Hospital
Xi'an, Shaanxi, China
Qianxian People's Hospital
Xianyang, Shaanxi, China
The First People' Hospital of Xian Yang
Xianyang, Shaanxi, China
Xianyang hospital affliated of Yan'an University
Xianyang, Shaanxi, China
The 970th Hospital of the Chinese People's Liberation Army (Weihai Branch)
Weihai, Shandong, China
The 970th Hospital of the Chinese People's Liberation Army (Yantai Branch)
Yantai, Shandong, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single (Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 2, 2022
First Posted
June 15, 2022
Study Start
February 21, 2023
Primary Completion
December 18, 2024
Study Completion
March 11, 2025
Last Updated
July 14, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
The study protocol,statistical analysis plan(SAP),informed consent form(ICF),clinical study report(CSR),analytic code will be shared with other researchers.