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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Peptic Ulcer With Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vonoprazan

Vonoprazan 20 mg oral every 12 hours (total 72 hours) then vonoprazan 20 mg oral once daily for 28 days

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Vonoprazan 20 mg oral every 12 hours (total 72 hours)

PPIs

PPIs IV infusion for 72 hours then oral PPIs twice per day for 28 days

Group Type ACTIVE_COMPARATOR

PPIs IV infusion

Intervention Type DRUG

Pantoprazole 80 mg IV loading then 8 mg/hr

Interventions

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Vonoprazan

Vonoprazan 20 mg oral every 12 hours (total 72 hours)

Intervention Type DRUG

PPIs IV infusion

Pantoprazole 80 mg IV loading then 8 mg/hr

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes