Comparing Vonoprazan and oral PPIs for bleeding peptic ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of oral Vonoprazan, a potassium-competitive acid blocker, against standard high-dose proton pump inhibitors (PPIs) in patients with bleeding peptic ulcers who have undergone successful endoscopic treatment. The study is a multicenter randomized controlled trial that hypothesizes that Vonoprazan will not be inferior to intravenous PPI therapy in preventing recurrent bleeding. The trial will assess outcomes such as rebleeding rates and overall patient recovery following treatment. By evaluating these two treatment options, the study seeks to provide insights into optimal management strategies for upper gastrointestinal bleeding.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- Patients aged ≥18 years who had undergone oesophagogastroduodenoscopy (OGD) for sign and symptoms of aneamia or upper GI bleeding including haematochezia, melaena or haematemesis, and found to a non-variceal upper GI cause of bleeding (peptic ulcers, dieulafoy's lesions, Mallory Weiss tear with active bleeding or major stigmata of haemorrhage
* Major stigmata of recent haemorrhage includes peptic ulcers with spurting or oozing bleeding (Forrest classification Ia and Ib, respectively) ,with a nonbleeding visible vessel (Forrest classification IIa) or an adherent clot (Forrest classification IIb). For peptic ulcers with an adherent clot (Forrest classification IIb), the clot would be lifted (by irrigation using syringe boluses or water pump device, or manipulation with a snare or alligator etc.) and ulcer base examined to look for underlying vessels. Once the clot is removed, any identified underlying active bleeding or nonbleeding visible vessel should receive endoscopic haemostasis
* Patients who had undergone endoscopic hemostatic treatment (a combination of hemoclipping therapy or contact thermocoagulation using multipolar/bipolar electrocautery probes or haemostatic forceps, with or without preinjection of diluted epinephrine. Endoscopic haemostasis is defined as no evidence of bleeding after irrigation and 3 minutes of observation

Exclusion Criteria:

* No consent
* Patients under the age of 18
* Patients who were pregnant or in lactation
* Hypersensitivity to PPI or Vonoprazan or any component of the formulation
* Patients who were found to have tumour bleeding, oesophageal varices as the cause of the NVGIB
* NVGIB due to post therapeutic endoscopic treatment such as gastric polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection etc.

Where it's running

• Nanfang Hospital Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
  Guangzhou, Guangdong, China Not yet recruiting
• Shenzhen Pingshan District People's Hospital
  Shenzhen, Guangdong, China Not yet recruiting
• The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen
  Shenzhen, Guangdong, China Not yet recruiting
• Yangjiang People's Hospital of Guangdong Medical University
  Yangjiang, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: xiaobei luo, PhD
• Email: luoxiaobei63@126.com
• Phone: 86 17688881428

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.