Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery

Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery (PANDA X)

Neurologic Dysfunction is one of the main factors contributing to poor outcomes in cardiac surgery patients, except for heart failure. Atherosclerosis of the aorta, a history of cerebral infarction, and cervical artery disease are common clinical risk factors for cerebral neurological dysfunction after cardiac surgery. Results of preclinical studies suggested that Angong Niuhuang Pills (ANPs), a traditional Chinese patent medicine, including realgar, cinnabaris, Bovis Calculus, artificial Moschus, and powdered buffalo horn extract, decreased infarct volume and cerebral edema, and presented anti- atherosclerosis and cardio-protective effects in clinical and preclinical studies. The PANDA X trial is designed as a pilot study to explore the safety and efficacy of ANP in patients with moderate-to-severe neurologic dysfunction after cardiovascular surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injury; Cardio-pulmonary Bypass; Cardiovascular Surgery; Cerebral Protection
• Intervention / Treatment: Drug: Angong Niuhuang Pill (ANP); Other: Control (Standard treatment)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong-feng Shao, MD; Phone Number: 02568303101; Email: yfshaojph@sina.com
• Study Contact Backup: Name: Hong Liu, MD; Phone Number: 18801281613; Email: DR.HONGLIU@FOXMAIL.COM

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Si-chong Qian, MD; Email: drqsc1990a@163.com
      • Contact: Hong-jia Zhang, MD
      • Contact: Hai-yang Liu, MD
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Hong Liu, MD
      • Contact: Wei Zhang, MD; Phone Number: 18801281613; Email: zhangweijph@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) an age > 18 years,
• (2) underwent cardiovascular surgery,
• (3) diagnosis of acute neurologic dysfunction, including but not limited acute cerebral infarction of the internal carotid artery system,
• (4) a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20,
• (5) a time from symptom onset to randomization within 36 h,
• (6) provision of informed consent.

Exclusion Criteria:

• (1) not suitable for taking ANP after the dialectical process by a traditional Chinese medical doctor,
• (2) received ANP within 1 month before stroke onset,
• (3) liver failure,
• (4) declined to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANP group	Drug: Angong Niuhuang Pill (ANP); Angong Niuhuang Pill (ANP) (3 g/pill, 1 pill/day for 5 days)
Other: Control; standard treatment	Other: Control (Standard treatment); Blank control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in the NIHSS score	a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20	after 14 days of randomization

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Beijing Anzhen Hospital, Capital Medicine University

Publications and helpful links

General Publications

• Li S, Wang A, Shi L, Liu Q, Guo X, Liu K, Wang X, Li J, Zhu J, Wu Q, Yang Q, Zhuang X, You H, Feng F, Luo Y, Li H, Ni J, Peng B. Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial. Chin Med J (Engl). 2024 Nov 6. doi: 10.1097/CM9.0000000000003133. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; Inflammatory Response
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Neurologic Manifestations; Brain Injuries
• Other Study ID Numbers: PANDA X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No