Trials / Completed
CompletedNCT05419193
PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)
Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Beijing Tiantan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Stroke
- Vascular Accident
- Intracranial Hemorrhages
- Intracerebral Hemorrhage
- Hemorrhagic Stroke
- Stroke, Acute
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Propranolol Hydrochloride | Day of randomization: propranolol IV vp for 7 days after randomization |
| OTHER | control group | Patients will receive usual care and drug use in hospital |
Timeline
- Start date
- 2023-02-21
- Primary completion
- 2024-12-18
- Completion
- 2025-03-11
- First posted
- 2022-06-15
- Last updated
- 2025-07-14
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05419193. Inclusion in this directory is not an endorsement.