Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding

NCT07772700 | Not Yet Recruiting

• 1 other identifier: A-BR-115-053
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bleeding

Keywords

PCAB; PPI; peptic ulcer bleeding; Rockall score; rebleeding

Outcome Measures

Primary Outcomes (1)

• Recurrent bleeding

  If melena or hematochezia occurs during follow-up, endoscopy will be performed to determine whether recurrent bleeding originates from the original bleeding lesion.

  28 days

Secondary Outcomes (2)

• Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding

  28 days

• Mortality

  28 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.

Drug: Vonoprazon

Standard group

ACTIVE COMPARATOR

After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.

Drug: Esomeprazole

Interventions

Vonoprazon DRUG

After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.

Intervention Group

Esomeprazole DRUG

After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.

Standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients \> 18 years with upper gastrointestinal ulcer bleeding, a Rockall score of 6 or higher, and treatment with endoscopic hemostasis.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Related Publications (6)

• Cheng HC, Wu CT, Chang WL, Cheng WC, Chen WY, Sheu BS. Double oral esomeprazole after a 3-day intravenous esomeprazole infusion reduces recurrent peptic ulcer bleeding in high-risk patients: a randomised controlled study. Gut. 2014 Dec;63(12):1864-72. doi: 10.1136/gutjnl-2013-306531. Epub 2014 Mar 21.

  PMID: 24658598 BACKGROUND

• Yang EH, Wu CT, Kuo HY, Chen WY, Sheu BS, Cheng HC. The recurrent bleeding risk of a Forrest IIc lesion at the second-look endoscopy can be indicated by high Rockall scores >/= 6. Surg Endosc. 2020 Apr;34(4):1592-1601. doi: 10.1007/s00464-019-06919-3. Epub 2019 Jun 20.

  PMID: 31222633 BACKGROUND

• Yang EH, Cheng HC, Wu CT, Chen WY, Lin MY, Sheu BS. Peptic ulcer bleeding patients with Rockall scores >/=6 are at risk of long-term ulcer rebleeding: A 3.5-year prospective longitudinal study. J Gastroenterol Hepatol. 2018 Jan;33(1):156-163. doi: 10.1111/jgh.13822.

  PMID: 28497645 BACKGROUND

• Kyaw MH, Lau JYW. High Rate of Mortality More Than 30 Days After Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1858-1859. doi: 10.1016/j.cgh.2017.08.002. Epub 2017 Aug 10. No abstract available.

  PMID: 28804035 BACKGROUND

• Laine L. Upper Gastrointestinal Bleeding Due to a Peptic Ulcer. N Engl J Med. 2016 Sep 22;375(12):1198. doi: 10.1056/NEJMc1609017. No abstract available.

  PMID: 27653581 BACKGROUND

• Jang Y, Park J, Kang D, Kim JH, Choi HS, Jeon HL, Lee H. Safety of Potassium-Competitive Acid Blockers Compared With Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease and Peptic Ulcer Disease: A Systematic Review and Meta-Analysis. J Gastroenterol Hepatol. 2026 Jan;41(1):28-40. doi: 10.1111/jgh.70178. Epub 2025 Dec 2.

  PMID: 41330871 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Peptic Ulcer Hemorrhage

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hsueh-Chien Chiang, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng-Hsuan Lu, MD

CONTACT

8862353535; cyes40327@gmail.com

Hsueh-Chien Chiang, MD

CONTACT

8862353535; scion456scion@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous pharmacological therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the intervention group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR