Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding: A Randomized Controlled Trial
| Registry | NCT07772700 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 108 (Estimated) |
| Sponsor | National Cheng-Kung University Hospital (Other) |
| Conditions | Bleeding |
| Interventions | Vonoprazon, Esomeprazole (Drug) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-08-19, last updated 2026-08-20 |
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All trials for Bleeding All trials of Vonoprazon All trials of Esomeprazole
This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher.
A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients.
Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous PPI therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the experimental group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.
Upper gastrointestinal bleeding is a common clinical condition associated with a substantial risk of mortality, with ulcer bleeding accounting for the majority of cases. Current standard treatment consists of pharmacological therapy combined with endoscopic hemostasis. Pharmacological therapy suppresses gastric acid secretion, reduces clot dissolution, and creates an environment conducive to mucosal healing.
Various scoring systems are used clinically to assess disease severity and prognosis in patients with ulcer bleeding. The Rockall score is one of the most commonly used systems. Patients with a Rockall score of 6 or higher have a higher risk of rebleeding and mortality. Therefore, high-risk patients are generally treated with twice-daily oral proton pump inhibitors (PPIs). However, twice-daily dosing may reduce medication adherence.
Potassium-competitive acid blockers (P-CABs) have emerged in recent years and offer several potential advantages, including rapid onset of action, potent acid suppression, stability in an acidic environment, and a long half-life. They may represent a new treatment option for peptic-ulcer disease. This study will therefore compare the efficacy of PPI and P-CAB therapy in preventing recurrent bleeding among patients with upper gastrointestinal ulcer bleeding and a Rockall score of 6 or higher.
This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher.
A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients.
Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous PPI therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the experimental group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group | Experimental | Drug: Vonoprazon | After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days. |
| Standard group | Active comparator | Drug: Esomeprazole | After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Hospitalized patients > 18 years with upper gastrointestinal ulcer bleeding, a Rockall score of 6 or higher, and treatment with endoscopic hemostasis. Exclusion Criteria: * history of hypersensitivity to PPIs or P-CABs. * non-ulcer-related bleeding, such as variceal bleeding, angiodysplasia, diverticular bleeding, diffuse mucosal bleeding, or tumor bleeding. * severe hepatic or renal impairment