Keverprazan vs Pantoprazole for the Treatment of ANVUGIB
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGeneral Hospital of Shenyang Military Region
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pantoprazole
DrugParticipants will receive oral Pantoprazole 40 mg once daily for 14 days.
Keverprazan
DrugParticipants will receive oral Keverprazan 20 mg once daily for 14 days.
Treatment groups
908 Participants
are divided into 2 treatment groupsGroup A: Keverprazan groupExperimental treatment 1 intervention
Group B: Pantoprazole groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of rebleeding.
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.
Time frame
From randomization up to Day 14.Secondary outcomes
1
Proportion of patients receiving blood transfusion
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.
Time frame
From randomization up to Day 14.2
Proportion of patients receiving endoscopic hemostasis, transcatheter arterial embolization, surgery for bleeding.
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.
Time frame
From randomization up to Day 14.3
All-cause mortality
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.
Time frame
From randomization up to Day 14.4
Incidence of adverse events
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.
Time frame
From randomization up to Day 14.Sponsors and contacts
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Source ClinicalTrials.gov
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