Clinical Trial: Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Long-term Prospective Cohort Study of Testing for Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding With Low-dose Aspirin

Brief Summary:

Low-dose aspirin (ASA) has emerged as the most important cause of peptic ulcer bleeding worldwide. In western countries, ASA has overtaken non steroidal antiinflammatory drugs (NSAIDs) as a major cause of peptic ulcer bleeding in the elderly population [1,2]. Management of peptic ulcer bleeding in patients receiving ASA for cardiothrombotic diseases is a clinical dilemma. In a randomized trial of continuous versus interrupted ASA therapy after endoscopic treatment of peptic ulcer bleeding, patients who discontinued ASA had a 10-fold increased incidence of all-cause mortality compared to those who received continuous ASA therapy. On the other hand, patients receiving continuous ASA therapy had a two-fold increased risk of early rebleeding [3]. Thus, preventing the occurrence of peptic ulcer bleeding in ASA users is important in reducing morbidity and mortality.

Given the uncertain clinical utility of Helicobacter Pylori (Hp) testing in ASA users, this prospective cohort study aims to determine whether testing for Hp will have any impact on the long-term incidence of ulcer bleeding in ASA users with high ulcer risk. The investigators hypothesize that among ASA users with Hp infection and ulcer bleeding, the long-term incidence of recurrent ulcer bleeding with ASA use will be low after eradication of Hp alone.

Detailed Summary:

Low-dose aspirin (ASA) has emerged as the most important cause of peptic ulcer bleeding worldwide. In western countries, ASA has overtaken NSAIDs as a major cause of peptic ulcer bleeding in the elderly population [1,2]. Management of peptic ulcer bleeding in patients receiving ASA for cardiothrombotic diseases is a clinical dilemma. In a randomized trial of continuous versus interrupted ASA therapy after endoscopic treatment of peptic ulcer bleeding, patients who discontinued ASA had a 10-fold increased incidence of all-cause mortality compared to those who received continuous ASA therapy. On the other hand, patients receiving continuous ASA therapy had a two-fold increased risk of early rebleeding [3]. Thus, preventing the occurrence of peptic ulcer bleeding in ASA users is important in reducing morbidity and mortality.

Emerging evidence from secondary analysis of cardiovascular trials suggests that aspirin also reduces the risk of all cancers, even at cardioprotective doses [4]. With increasing use of ASA for cardiothrombotic diseases and cancer prevention, the global burden of ASA-associated peptic ulcer disease is expected to increase.

A number of risk factors are known to increase the risk of peptic ulcer bleeding with ASA use. These include a history of peptic ulcer or ulcer bleeding, old age, renal failure, concurrent use of ASA and clopidogrel, and Helicobacter pylori (Hp) infection [5-7]. Among these risk factors, concomitant use of clopidogrel and a history of peptic ulcer bleeding and are important predictors of ulcer bleeding with ASA use [7]. On the other hand, Hp is the only risk factor that can be modified. Eradication of Hp therefore offers a hope of reducing the risk of ulcer bleeding in ASA users.

Current European and U.S. guidelines unanimously recommend
Sponsor: Chinese University of Hong Kong

Current Primary Outcome: The cumulative incidence of gastroduodenal ulcer bleeding [ Time Frame: 10 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Chinese University of Hong Kong

Dates:
Date Received: April 25, 2012
Date Started: January 1995
Date Completion:
Last Updated: August 10, 2015
Last Verified: November 2014