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

Uayporn Kaosombatwattana

Status and phase: Completed; Early Phase 1

Conditions: Peptic Ulcer With Haemorrhage

Treatments: Drug: PPIs IV infusion; Drug: Vonoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT05005910

011/2563

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Vonoprazan

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan

PPIs

Active Comparator group

Description:

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

Treatment:

Drug: PPIs IV infusion