Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Early Phase 1

Completed

• Conditions: Peptic Ulcer With Haemorrhage
• Interventions: Drug: PPIs IV infusion; Drug: Vonoprazan

• Registration Number: NCT05005910
• Lead Sponsor: Uayporn Kaosombatwattana

Brief Summary

Upper gastrointestinal hemorrhage (UGIH) is common urgency condition.The estimate mortality rate about 7 percent from peptic ulcers disease(PUD). A proton pump inhibitors (PPIs) intravenous infusion are standard treatment for high risk ulcer bleeding. Vonoprazan,subclass of potassium-competitive acid blockers (P-CABs), have beneficial effects including rapid, long-lasting and strong acid suppression.The investigators design a randomized-controlled trial comparison between 72 hours of intravenous PPIs infusion and oral vonoprazan in high risk ulcer UGIH after achieve endoscopic hemostasis. Outcome measurement are re-bleeding rate in 30 days as primary and re-bleeding rate in 3 days, 30 days mortality, rate of angioembolisation, unit of blood transfusion, hospital cost and length of stay as secondary outcome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-12
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-16
• Study Start: 2021-09-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• High risk peptic ulcers bleeding (Forrest class Ia,Ib,IIa,IIb)

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Exclusion Criteria

• Patients were not achieve endoscopic hemostasis
• End stage cancer disease
• Severe critical illness and ICU setting
• Uncorrectable coagulopathy
• Pregnancy or breast feeding
• Allergy to PPIs or Vonoprazan

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPIs	PPIs IV infusion	PPIs IV infusion for 72 hours then oral PPIs twice per day for 28 days
Vonoprazan	Vonoprazan	Vonoprazan 20 mg oral every 12 hours (total 72 hours) then vonoprazan 20 mg oral once daily for 28 days

Primary Outcome Measures

Name	Time	Method
Rebleeding rate	30 days

Secondary Outcome Measures

Name	Time	Method
Rebleeding rate	3 days
Mortality rate	30 days
Length of stay	Until discharge, assessed up to 30 days
Rate of immobilisation or surgery	30 days
Number of blood transfusion unit	30 days

Trial Locations

Locations (1)

Faculty of internal medicine siriraj hospital, Mahidol university; 🇹🇭 Bangkok Noi, Bangkok, Thailand