Keverprazan vs Pantoprazole for the Treatment of ANVUGIB

Keverprazan Versus Pantoprazole for the Treatment of Acute Non Variceal Upper Gastrointestinal Bleeding: Protocol of a Prospective, Multicenter, Non Inferiority, Randomized Controlled Trial

Acute non-variceal upper gastrointestinal bleeding (ANVUGIB) is a common medical emergency requiring hospitalization. The cornerstone of ANVUGIB management is effective gastric acid suppression. Potassium-competitive acid blockers (P-CABs) represent a novel class of gastric acid secretion inhibitors, which can rapidly and consistently increase intragastric pH. Keverprazan, a novel P-CAB, has been shown to be effective in treating duodenal ulcers and erosive esophagitis. Herein, we have designed a multicenter randomized controlled trial (RCT) to determine whether keverprazan is noninferior to pantoprazole in preventing rebleeding after successful initial hemostasis in patients with ANVUGIB.

Inclusion criteria are as follows:

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

Exclusion criteria are as follows:

1. 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.
2. Participants have an active malignancy or malignancy expected to interfere with survival, outcome assessment, treatment adherence, or follow-up.
3. Participants have esophageal or gastric varices or portal hypertensive gastropathy identified during endoscopic examination.
4. Participants who are unable to swallow the study medication.
5. Participants have a history of partial or total gastrectomy, gastric bypass surgery, or other major surgery.
6. Severe organ dysfunction, including any of the following: Severe hepatic or renal impairment; Unstable or severe cardiovascular, respiratory, neurological, or other systemic disease.
7. Zollinger-Ellison syndrome.
8. Any contraindication to keverprazan or pantoprazole, including known hypersensitivity to either medication or any of their components.
9. Pregnancy or lactation.
10. Participation in another clinical study within 3 months before enrollment.
11. Other situations considered by the investigator as unsuitable for enrollment.