Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01408186
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2011-08-02
Brief Title:
ASP PPI_H2RA Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Histamine-2 Receptor Antagonist Versus Proton-Pump Inhibitor for the Prevention of Recurrent Upper Gastrointestinal Bleeding UGI in High-risk Users of Low-dose Aspirin ASA
Status:
COMPLETED
Status Verified Date:
2017-04
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:
None
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 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 15 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
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
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 This rise in the incidence was associated with a 44 increase in usage of ASA In Hong Kong ASA is also a major cause of peptic ulcer complications
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 Among these preventive strategies co-therapy with a PPI for prevention of ulcer bleeding in high-risk ASA users remains the most studied and best proven strategy
H2-receptor antagonists H2RAs are relatively weak acid suppressing drugs when compared to PPIs Very few studies have evaluated the efficacy of H2RAs in the prevention of peptic ulcer bleeding with ASA Two case-control studies yielded conflicting results with regard to the efficacy of H2RAs in reducing the risk of hospitalizations for ulcer bleeding with ASA There is a limited data on the efficacy of H2RAs however our local health authority has endorsed the use of H2RA as a co-therapy in high-risk ASA users since 2001
On the other hand H2RAs have two potential advantages over PPIs First generic H2RAs are much cheaper than generic PPIs in Hong Kong Second unlike the interaction between PPIs and clopidogrel concomitant use of H2RAs and clopidogrel is not associated with an increased risk of recurrent myocardial infarction Thus H2RA might be a cheap and safe gastroprotective drug in patients requiring dual anti-platelet therapy ie ASA and clopidogrel who require coronary stents
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 we have shown that discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a significantly increased in mortality within 8 weeks
The investigators aim to test the hypothesis that PPI is superior to H2RA for the prevention of recurrent upper gastrointestinal bleeding in ASA users with a history ulcer bleeding
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 Among these preventive strategies co-therapy with a PPI for prevention of ulcer bleeding in high-risk ASA users remains the most studied and best proven strategy
H2-receptor antagonists H2RAs are relatively weak acid suppressing drugs when compared to PPIs Very few studies have evaluated the efficacy of H2RAs in the prevention of peptic ulcer bleeding with ASA Two case-control studies yielded conflicting results with regard to the efficacy of H2RAs in reducing the risk of hospitalizations for ulcer bleeding with ASA There is a limited data on the efficacy of H2RAs however our local health authority has endorsed the use of H2RA as a co-therapy in high-risk ASA users since 2001
On the other hand H2RAs have two potential advantages over PPIs First generic H2RAs are much cheaper than generic PPIs in Hong Kong Second unlike the interaction between PPIs and clopidogrel concomitant use of H2RAs and clopidogrel is not associated with an increased risk of recurrent myocardial infarction Thus H2RA might be a cheap and safe gastroprotective drug in patients requiring dual anti-platelet therapy ie ASA and clopidogrel who require coronary stents
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 we have shown that discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a significantly increased in mortality within 8 weeks
The investigators aim to test the hypothesis that PPI is superior to H2RA for the prevention of recurrent upper gastrointestinal bleeding in ASA users with a history ulcer bleeding
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