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

• Status: Enrolling by invitation
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Uayporn Kaosombatwattana

Criteria

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