Status:
COMPLETED
ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Upper Gastrointestinal Bleeding
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half of all cases of ho...
Detailed Description
No dose of "low-dose" aspirin (ASA) is safe in terms of the risk if ulcer bleeding. Even at a dose as low as 75 mg daily, ASA doubles the risk of ulcer bleeding when compared to the risk in non-users....
Eligibility Criteria
Inclusion
- A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable)
- Negative tests for H. pylori or successful eradication of H. pylori based on urease test or histology
- Expected regular use of ASA for the duration of the trial
- Age ≥ 18
- Written informed consent obtained
Exclusion
- A history of gastric or duodenal surgery other than patch repair
- Severe erosive esophagitis (LA grade C or D)
- Gastric outlet obstruction
- Terminal illness
- Active malignancies
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT01408186
Start Date
January 1 2011
End Date
November 1 2016
Last Update
April 21 2017
Active Locations (8)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong
2
Second Department of Internal Medicine, Shimane University Faculty of Medicine, Izumo, Japan
Izumo, Japan
3
Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan
Kyoto, Japan
4
Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan (Satellite hospital of Osaka City University)
Osaka, Japan