Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT05419193
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2022-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)
Sponsor:
Beijing Tiantan Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-CHASE
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: