Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01278550
First received: January 18, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition
Ulcer Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin (NSAID#2NANC Study)

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Ulcer complications, defined as bleeding or perforation [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 503
Study Start Date: January 1995
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

High-risk patients were from our hospital while average-risk patients were from our out-patient clinics

Criteria

High-risk cohort

Inclusion criteria:

Patients must fulfill ALL of the following:

  1. History of endoscopically confirmed ulcer bleeding
  2. Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis
  3. Successful eradication of H. pylori based on histology

Exclusion criteria:

  1. Concomitant use of anti-ulcer drug, anticoagulant, non-aspirin NSAIDs or steroids
  2. Previous acid-reduction gastric surgery
  3. Gastric outlet obstruction, erosive esophagitis, gastroesophageal varices
  4. Moribund or incurable cancers

Average-risk cohort

Inclusion criteria:

Patients must fulfill ALL of the following:

  1. No history of ulcer bleeding
  2. Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis
  3. H. pylori positive OR negative

Exclusion criteria:

  1. Concomitant use of anti-ulcer drug, anticoagulant, non-aspirin NSAIDs or steroid
  2. Previous acid-reduction gastric surgery
  3. Moribund or incurable cancers
  4. Previous attempts of H. pylori eradication
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01278550

Locations
China
Prince of Wales Hospital
Hong Kong (SAR), China, 852
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Francis KL CHAN, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Francis KL Chan, professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01278550     History of Changes
Other Study ID Numbers: 2NANC
Study First Received: January 18, 2011
Last Updated: February 18, 2014
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Hemorrhage
Ulcer
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014