Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01278550
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2011-01-18
Brief Title:
Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin NSAID2NANC Study
Status:
COMPLETED
Status Verified Date:
2015-08
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:
Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and stroke However low-dose aspirin increases the risk of ulcer bleeding Current evidence indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events and the risk of ulcer bleeding is low about 1 per year Since the overall risk of bleeding is low aspirin users who do not have previous ulcer disease do not require prophylaxis with anti-ulcer drugs In contrast aspirin users with a history of ulcer disease have a 2- to 4-fold increased risk of ulcer bleeding The best strategy for reducing the risk of bleeding in high-risk aspirin users remains unclear Current strategies for high-risk patients include the use of anti-ulcer drugs elimination of risk factors eg Helicobacter pylori Recently the investigators have shown that among aspirin users who are infected with H pylori the eradication of H pylori is comparable to omeprazole a proton pump inhibitor PPI in preventing recurrent ulcer bleeding in 6 months
The investigators postulated that among patients with H pylori infection and a history of ulcer bleeding who continue to use low-dose aspirin the long-term risk of ulcer complications after eradication of H pylori is comparable to that of average-risk aspirin users
The investigators postulated that among patients with H pylori infection and a history of ulcer bleeding who continue to use low-dose aspirin the long-term risk of ulcer complications after eradication of H pylori is comparable to that of average-risk aspirin users
Detailed Description:
Low-dose aspirin is increasingly used for the prophylaxis against coronary heart disease and stroke However it is also an important cause of peptic ulcer bleeding worldwide In England and Wales low-dose aspirin is estimated to account for about 10 of ulcer bleeding in people aged 60 and over Weil 1995 The problem of aspirin-related ulcer disease is expanding with the increasing use of aspirin for cardiovascular prophylaxis
No dose of aspirin is entirely free of risk Using a daily dose of aspirin as low as 75 mg the risk of ulcer bleeding doubles that of non-users Weil 1995 Previous ulcer disease and concurrent major medical illnesses are important risk factors for ulcer bleeding with low-dose aspirin Among aspirin users those with previous ulcer disease have a 5-fold increased risk of ulcer bleeding Lanas 2000 Recently the investigators have shown that among aspirin users who are infected with H pylori the eradication of H pylori is comparable to omeprazole in preventing recurrent ulcer bleeding in 6 months Chan 2001 However whether curing H pylori infection would confer long-term protection against ulcer bleeding for patients requiring life-long aspirin is uncertain
To compare the long-term risk of ulcer complications in high-risk aspirin users after eradication of H pylori with that of average-risk aspirin users The latter is defined as patients who have no prior history of ulcer bleeding
The investigators postulated that among patients with H pylori infection and a history of ulcer bleeding who continue to use low-dose aspirin the long-term risk of ulcer complications after eradication of H pylori is comparable to that of average-risk aspirin users
References Weil J Colin-Jones D Langman M et al Prophylactic aspirin and risk of peptic ulcer bleeding Br Med J 1005310827-30
Lanas A Bajador E Serrano P et al Nitrovasodilators low-dose aspirin other nonsteroidal antiinflammatory drugs and the risk of upper gastrointestinal bleeding N Engl J Med 2000343834-9
Chan FKL Chung SCS Suen BY et al Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen N Engl J Med 2001344967-73
No dose of aspirin is entirely free of risk Using a daily dose of aspirin as low as 75 mg the risk of ulcer bleeding doubles that of non-users Weil 1995 Previous ulcer disease and concurrent major medical illnesses are important risk factors for ulcer bleeding with low-dose aspirin Among aspirin users those with previous ulcer disease have a 5-fold increased risk of ulcer bleeding Lanas 2000 Recently the investigators have shown that among aspirin users who are infected with H pylori the eradication of H pylori is comparable to omeprazole in preventing recurrent ulcer bleeding in 6 months Chan 2001 However whether curing H pylori infection would confer long-term protection against ulcer bleeding for patients requiring life-long aspirin is uncertain
To compare the long-term risk of ulcer complications in high-risk aspirin users after eradication of H pylori with that of average-risk aspirin users The latter is defined as patients who have no prior history of ulcer bleeding
The investigators postulated that among patients with H pylori infection and a history of ulcer bleeding who continue to use low-dose aspirin the long-term risk of ulcer complications after eradication of H pylori is comparable to that of average-risk aspirin users
References Weil J Colin-Jones D Langman M et al Prophylactic aspirin and risk of peptic ulcer bleeding Br Med J 1005310827-30
Lanas A Bajador E Serrano P et al Nitrovasodilators low-dose aspirin other nonsteroidal antiinflammatory drugs and the risk of upper gastrointestinal bleeding N Engl J Med 2000343834-9
Chan FKL Chung SCS Suen BY et al Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen N Engl J Med 2001344967-73
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