Keverprazan vs Pantoprazole for the Treatment of ANVUGIB

This is a non-inferiority, randomized controlled trial. A total of 908 patients will be enrolled and stratified into high- and low-risk bleeding groups according to the GBS. Patients in the high-risk group will continue to receive high-dose intravenous PPI at a dosage of 8mg/h for 72 hours; and then those without rebleeding during this period will be randomized. Patients in the low-risk group will directly randomized. Eligible patients will be randomly assigned in a 1:1 ratio to receive keverprazan or pantoprazole. The primary endpoint will be the 14-day incidence of rebleeding. Secondary endpoints will include 1) the proportion of patients receiving blood transfusion, 2) additional endoscopic hemostasis or surgical or radiologic intervention, 3) all-cause mortality, and 4) adverse events within 14 days.

Inclusion criteria

are as follows:

• Participants presented with hematemesis, melena, or other clinical manifestations suggestive of upper gastrointestinal bleeding within 5 days before screening.
• Participants have endoscopic confirmation of a non-variceal source of upper gastrointestinal bleeding.
• Participants are aged between 18 and 75 years.
• Participants who are willing to participate in this clinical trial and sign the written informed consent.

Exclusion criteria

are as follows:

• Participants have experienced failure of endoscopic hemostasis, rebleeding before randomization, or a requirement for immediate transcatheter arterial embolization or surgery at the time of eligibility assessment.
• Participants have an active malignancy or malignancy expected to interfere with survival, outcome assessment, treatment adherence, or follow-up.
• Participants have esophageal or gastric varices or portal hypertensive gastropathy identified during endoscopic examination.
• Participants who are unable to swallow the study medication.
• Participants have a history of partial or total gastrectomy, gastric bypass surgery, or other major surgery.
• Severe organ dysfunction, including any of the following: Severe hepatic or renal impairment; Unstable or severe cardiovascular, respiratory, neurological, or other systemic disease.
• Zollinger-Ellison syndrome.
• Any contraindication to keverprazan or pantoprazole, including known hypersensitivity to either medication or any of their components.
• Pregnancy or lactation.
• Participation in another clinical study within 3 months before enrollment.
• Other situations considered by the investigator as unsuitable for enrollment.