Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01591486
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2012-04-25
Brief Title:
Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2NA3NANC
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 12 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
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 Description:
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 12 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 US guidelines unanimously recommend test-and-treat Hp infection in ASA users who are at risk of ulcer bleeding 8-10 Despite these guidelines the long-term benefit of eradicating Hp in high-risk ASA users is uncertain
In a 6-month randomized trial of ASA users with Hp infection complicated by ulcer bleeding patients were randomized to one-week of Hp eradication therapy alone or maintenance treatment with omeprazole after ulcers has healed Our results showed that the incidence of recurrent ulcer bleeding was comparable between the group receiving Hp eradication alone 19 and the group receiving omeprazole 09 11 In another 12-month randomized trial ASA users with Hp infection complicated by ulcer bleeding were randomized to one-week of eradication therapy alone or one week of eradication therapy plus maintenance treatment with lansoprazole In this study up to 15 of ASA users developed recurrent ulcer bleeding after eradication of Hp alone Among the ASA users who developed recurrent ulcer bleeding however over two-thirds had failure Hp eradication or used concomitant NSAIDs 12
In light of these conflicting findings current guidelines recommend that co-therapy with a proton-pump inhibitor PPI is still needed in high-risk ASA users after eradication of Hp 8-10 Since PPIs are more effective in preventing ASA-associated ulcers in the presence of Hp infection 13 the clinical relevance of testing for Hp in high-risk ASA users becomes even more questionable To date the strategy of test-and-treat Hp for ASA users is not popular among primary care doctors or specialists
One alternative gastroprotective strategy is to prescribe PPIs to all ASA users at high risk of ulcer bleeding and ignore Hp testing However poor compliance to gastroprotective co-therapy limits its effectiveness Recently health authorities issued warning about the the use of PPI and the risk of hip fractures and potential adverse drug-interactions between PPI and clopidogrel 1415 Clopidgorel is commonly used in combination with ASA for preventing coronary stent thrombosis but dual anti-platelet therapy will substantially increase the risk of ulcer bleeding 5 If eradication of Hp can reduce the long-term risk of ulcer bleeding with ASA use there may be a potential hope of limiting PPI use to very high risk ASA users
Given the uncertain clinical utility of 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
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 US guidelines unanimously recommend test-and-treat Hp infection in ASA users who are at risk of ulcer bleeding 8-10 Despite these guidelines the long-term benefit of eradicating Hp in high-risk ASA users is uncertain
In a 6-month randomized trial of ASA users with Hp infection complicated by ulcer bleeding patients were randomized to one-week of Hp eradication therapy alone or maintenance treatment with omeprazole after ulcers has healed Our results showed that the incidence of recurrent ulcer bleeding was comparable between the group receiving Hp eradication alone 19 and the group receiving omeprazole 09 11 In another 12-month randomized trial ASA users with Hp infection complicated by ulcer bleeding were randomized to one-week of eradication therapy alone or one week of eradication therapy plus maintenance treatment with lansoprazole In this study up to 15 of ASA users developed recurrent ulcer bleeding after eradication of Hp alone Among the ASA users who developed recurrent ulcer bleeding however over two-thirds had failure Hp eradication or used concomitant NSAIDs 12
In light of these conflicting findings current guidelines recommend that co-therapy with a proton-pump inhibitor PPI is still needed in high-risk ASA users after eradication of Hp 8-10 Since PPIs are more effective in preventing ASA-associated ulcers in the presence of Hp infection 13 the clinical relevance of testing for Hp in high-risk ASA users becomes even more questionable To date the strategy of test-and-treat Hp for ASA users is not popular among primary care doctors or specialists
One alternative gastroprotective strategy is to prescribe PPIs to all ASA users at high risk of ulcer bleeding and ignore Hp testing However poor compliance to gastroprotective co-therapy limits its effectiveness Recently health authorities issued warning about the the use of PPI and the risk of hip fractures and potential adverse drug-interactions between PPI and clopidogrel 1415 Clopidgorel is commonly used in combination with ASA for preventing coronary stent thrombosis but dual anti-platelet therapy will substantially increase the risk of ulcer bleeding 5 If eradication of Hp can reduce the long-term risk of ulcer bleeding with ASA use there may be a potential hope of limiting PPI use to very high risk ASA users
Given the uncertain clinical utility of 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None