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临床试验/NCT05005910
NCT05005910已完成早期 1 期

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

Uayporn Kaosombatwattana1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
194
试验地点
1
主要终点
Rebleeding rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Vonoprazan

Experimental

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

干预措施: Vonoprazan (Drug)

PPIs

Active Comparator

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

干预措施: PPIs IV infusion (Drug)

结局指标

主要结局

Rebleeding rate

时间窗: 30 days

次要结局

  • 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)

研究者

发起方
Uayporn Kaosombatwattana
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Uayporn Kaosombatwattana

Lecturer

Mahidol University

研究点 (1)

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