Clinical trial NCT05005910: Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis
Official title: Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Peptic Ulcer With Haemorrhage
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rebleeding rate
timeFrame: 30 days
Secondary outcomes:
measure: Rebleeding rate
timeFrame: 3 days
measure: Mortality rate
timeFrame: 30 days
measure: Number of blood transfusion unit
timeFrame: 30 days
measure: Rate of immobilisation or surgery
timeFrame: 30 days
measure: Length of stay
timeFrame: Until discharge, assessed up to 30 days
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of internal medicine siriraj hospital, Mahidol university
state: Bangkok
Study officials:
References:
citation: Sung JJ, Suen BY, Wu JC, Lau JY, Ching JY, Lee VW, Chiu PW, Tsoi KK, Chan FK. Effects of intravenous and oral esomeprazole in the prevention of recurrent bleeding from peptic ulcers after endoscopic therapy. Am J Gastroenterol. 2014 Jul;109(7):1005-10. doi: 10.1038/ajg.2014.105. Epub 2014 Apr 29.
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citation: Sugano K, Kontani T, Katsuo S, Takei Y, Sakaki N, Ashida K, Mizokami Y, Asaka M, Matsui S, Kanto T, Soen S, Takeuchi T, Hiraishi H, Hiramatsu N. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial. J Gastroenterol. 2012 May;47(5):540-52. doi: 10.1007/s00535-012-0541-z. Epub 2012 Mar 3.