Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding (2NA3NANC)
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|ClinicalTrials.gov Identifier: NCT01591486|
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : August 13, 2015
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 . 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.
|Condition or disease|
|Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Peptic Ulcer Bleeding|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||904 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||January 1995|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||March 2013|
The second cohort consists of ASA users with ulcer bleeding but no current or past Hp infection, as evidenced by:
After ulcer healing, the Hp-negative cohort will receive enteric-coated ASA (<160 mg daily) without regular co-prescription of anti-ulcer drugs.
Hp-eradicated cohort This cohort consists of ASA users with ulcer bleeding and Hp infection who have healed ulcers and successful eradication of Hp on follow-up endoscopy. They will receive plain ASA (<160 mg daily) without co-prescription of anti-ulcer drugs.
Average-risk cohort The third cohort consists of ASA-naive patients without a history of ulcer who attend the general outpatient clinic. They require long-term ASA for established cardiothrombotic diseases. They receive plain ASA (<160 mg daily) without co-prescription of anti-ulcer drugs. Hp status will not be determined in this cohort because Hp testing is not justified in average-risk asymptomatic patients.
- The cumulative incidence of gastroduodenal ulcer bleeding [ Time Frame: 10 years ]The cumulative incidence of gastroduodenal ulcer bleeding with ASA use in 10 years. Gastroduodenal ulcer bleeding is defined as haematemesis and/or melaena with gastroduodenal ulcers, or erosions with blood in the stomach confirmed by endoscopy, or a decrease in the haemoglobin level >2 g/dL in the presence of endoscopically proven ulcers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591486
|Endoscopy Center, Prince of Wales Hospital|
|Hong Kong (SAR), China, 852|
|Principal Investigator:||Francis KL CHAN, MD||Chinese University of Hong Kong|