- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278550
Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin
Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin (NSAID#2NANC Study)
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 (e.g. 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.
Study Overview
Status
Conditions
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 1005;310:827-30.
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 2000;343:834-9.
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 2001;344:967-73.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Hong Kong (SAR), China, 852
- Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
High-risk cohort
Inclusion criteria:
Patients must fulfill ALL of the following:
- History of endoscopically confirmed ulcer bleeding
- Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis
- Successful eradication of H. pylori based on histology
Exclusion criteria:
- Concomitant use of anti-ulcer drug, anticoagulant, non-aspirin NSAIDs or steroids
- Previous acid-reduction gastric surgery
- Gastric outlet obstruction, erosive esophagitis, gastroesophageal varices
- Moribund or incurable cancers
Average-risk cohort
Inclusion criteria:
Patients must fulfill ALL of the following:
- No history of ulcer bleeding
- Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis
- H. pylori positive OR negative
Exclusion criteria:
- Concomitant use of anti-ulcer drug, anticoagulant, non-aspirin NSAIDs or steroid
- Previous acid-reduction gastric surgery
- Moribund or incurable cancers
- Previous attempts of H. pylori eradication
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Average risk cohort
Patients having no history of endoscopically confirmed ulcer bleeding, need long-term aspirin for cardiovascular or cerebrovascular prophylaxis and have H. pylori positive OR negative
|
High risk cohort
Patients have history of endoscopically confirmed ulcer bleeding, need long-term aspirin for cardiovascular or cerebrovascular prophylaxis and have successful eradication of H. pylori based on histology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ulcer complications, defined as bleeding or perforation
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2NANC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ulcer Hemorrhage
-
Chinese University of Hong KongCompletedUlcer HemorrhageChina, Japan
-
Damascus HospitalCompletedPeptic Ulcer Hemorrhage | Marginal Ulcer | Gastroduodenal UlcerSyrian Arab Republic
-
AdventHealthCompletedPeptic Ulcer Hemorrhage | Peptic Ulcer, Acute With HemorrhageUnited States
-
Damascus HospitalWithdrawnPeptic Ulcer Hemorrhage | Marginal Ulcer | Gastroduodenal UlcerSyrian Arab Republic
-
Mercy Health SystemRecruitingUpper GI Bleeding | Bleeds Gastric | Bleed Ulcer | Hemorrhage Gastric | Hemorrhage; UlcerUnited States
-
National Cheng-Kung University HospitalNational Science Council, TaiwanCompleted
-
Uayporn KaosombatwattanaCompleted
-
Chinese University of Hong KongKarolinska University Hospital; King Chulalongkorn Memorial Hospital; Erasme...TerminatedBleeding | Peptic UlcerChina
-
Joon Sung KimCompletedPeptic Ulcer BleedingKorea, Republic of
-
National Cheng-Kung University HospitalCompletedPeptic Ulcer HemorrhageTaiwan