Non-variceal Upper Gastrointestinal Bleeding
Conditions
Keywords
non-variceal upper gastrointestinal bleeding, proton pump inhibitors, potassium-competitive acid blockers, keverprazan, pantoprazole
Brief summary
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.
Detailed description
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.
Interventions
DRUGPantoprazole
Participants will receive oral Pantoprazole 40 mg once daily for 14 days.
DRUGKeverprazan
Participants will receive oral Keverprazan 20 mg once daily for 14 days.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of rebleeding. | From randomization up to Day 14. | The proportion of patients who experience at least one episode of rebleeding after initial hemostasis from randomization up to Day 14. Rebleeding is defined as the recurrence of bleeding after initial hemostasis, including repeated hematemesis and/or melena, hemodynamic instability, or a decrease in hemoglobin of more than 2g/dL. The proportion will be calculated as the number of patients with rebleeding divided by the total number of patients assigned. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients receiving blood transfusion | From randomization up to Day 14. | The proportion of patients who receive at least one transfusion of red blood cells after randomization up to Day 14. The proportion will be calculated as the number of patients receiving blood transfusion divided by the total number of patients assigned. |
| Proportion of patients receiving endoscopic hemostasis, transcatheter arterial embolization, surgery for bleeding. | From randomization up to Day 14. | The proportion of patients who undergo at least one additional hemostatic intervention due to rebleeding after randomization up to Day 14. Additional hemostatic interventions include repeat endoscopic hemostasis, transcatheter arterial embolization, and surgery for rebleeding. The proportion will be calculated as the number of patients receiving at least one additional hemostatic intervention divided by the total number of patients assigned. |
| All-cause mortality | From randomization up to Day 14. | The proportion of patients who die from any cause after randomization up to Day 14. The proportion will be calculated as the number of patients who die from any cause divided by the total number of patients assigned. |
| Incidence of adverse events | From randomization up to Day 14. | The proportion of patients who experience at least one adverse event after randomization up to Day 14. The proportion will be calculated as the number of patients with at least one adverse event divided by the total number of patients assigned. Adverse events will be coded and classified according to the prespecified adverse-event assessment criteria in the study protocol. |
Countries
China
Contacts
CONTACTXingshun Qi
Outcome results
None listed