Clinical trial NCT06723366: Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery
Official title: Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery (PANDA X)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardio-pulmonary Bypass
Cardiovascular Surgery
Cerebral Protection
Brain Injury
Keywords: Inflammatory Response
cardiopulmonary bypass
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Beijing Anzhen Hospital, Capital Medicine University
First posted: 2024-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: changes in the NIHSS score
timeFrame: after 14 days of randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
citation: 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;138(5):579-88. doi: 10.1097/CM9.0000000000003133. Online ahead of print.