Upper Gastrointestinal Bleeding | ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA
Upper Gastrointestinal Bleeding research study
What is the primary objective of this study?
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 hospitalizations for peptic ulcer bleeding. Currently, ASA use has contributed to about one-third of the bleeding ulcers admitted to the investigators hospital that serves a local population of 1.5 million. In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a major dilemma. In another double-blind randomized trial, the investigators have shown that discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a significantly increased in mortality within 8 weeks. In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the dominant preventive strategy. Given the vast number of people taking ASA, however, it is only cost-effective to identify and treat those who are at high risk of ulcer bleeding and who have a strong indication for ASA use. Data from observational studies and randomized trials have consistently shown that PPIs are effective in reducing the risk of ulcer bleeding associated with ASA. Other potential preventive strategies include eradication of H. pylori infection, substitution of ASA for other non-aspirin anti-platelet drugs, and co-therapy with misoprostol or H2RAs.
Who is eligible to participate?
Inclusion Criteria: 1. A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable) 2. Negative tests for H. pylori or successful eradication of H. pylori based on urease test or histology 3. Expected regular use of ASA for the duration of the trial 4. Age ≥ 18 5. Written informed consent obtained Exclusion Criteria: 1. A history of gastric or duodenal surgery other than patch repair 2. Severe erosive esophagitis (LA grade C or D) 3. Gastric outlet obstruction 4. Terminal illness 5. Active malignancies
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Upper Gastrointestinal Bleeding
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RabeprazoleRabeprazole 20 mg daily
Drug:FamotidineFamotidine 40mg daily
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RabeprazoleTablet 20mg daily for 12 months
FamotidineTablet 40mg daily for 12 months
Start Date: January 2011
Completed Date: November 2016
Phase: Phase 3
Primary Outcome: recurrent non-variceal upper GI bleeding
Secondary Outcome: lower GI bleeding
Study sponsors, principal investigator, and references
Principal Investigator: Francis KL Chan, MD
Lead Sponsor: Chinese University of Hong Kong