Compound Vitamin B tablet
Drugperioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery
NCT Number: NCT07348328
This study is a multicenter, randomized controlled, double-blind, placebo-controlled parallel trial designed to evaluate the effect of perioperative supplementation with Compound Vitamin B on patients undergoing cardiovascular surgery. A total of 1,000 patients aged 18-80 years who are scheduled to receive cardiovascular surgeries such as coronary artery bypass grafting (CABG) and valve replacement will be enrolled. They will be randomly assigned at a 1:1 ratio to either the experimental group (perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery) or the control group (oral placebo), with both groups receiving standardized perioperative treatment.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Shanghai East Hospital Tongji University, Shanghai, DR, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery
perioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery
Time frame: within 6 months after surgery between the two groups
MACE is defined as a composite endpoint, including: cardiac death, non-fatal myocardial infarction (postoperative troponin peak > 10 times the upper limit of normal accompanied by chest pain and dynamic changes in electrocardiogram), ischemic stroke (new-onset neurological deficits after surgery confirmed by cranial CT/MRI), severe arrhythmia (sustained ventricular tachycardia, ventricular fibrillation, third-degree atrioventricular block requiring implantation of a temporary/permanent pacemaker), and readmission due to cardiac causes.
Contact information is provided by the study sponsor or research team.
Nanjing Medical University
Other
Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery: A Randomized Controlled Trial
Acronym: PANDA XII
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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