Prevention of Recurrent Ulcer Bleeding in High-risk Aspirin Users Who Are Not Infected With Helicobacter Pylori

NCT01274767 | Completed

• 1 other identifier: 3NANC
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 1

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 (e.g. Helicobacter pylori), or the use of enteric-coated aspirin. Although co-therapy of aspirin with an acid suppressant reduces the risk of ulcer bleeding, drug compliance may limit its clinical usefulness particularly in patients who are already receiving multiple drugs. The efficacy of enteric-coated aspirin in preventing ulcer complications showed conflicting results. One study found that enteric-coated aspirin increases the risk of ulcer bleeding. A recent study showed that enteric-coated aspirin causes minimal acute gastric injury. The investigators postulated that among patients without H. pylori infection and a history of ulcer bleeding who continue to use low-dose aspirin, enteric-coated aspirin reduces the long-term risk of ulcer complications to a level that is comparable to that of average-risk aspirin users.

Conditions

Ulcer Bleeding

Outcome Measures

Primary Outcomes (1)

• Ulcer complications

  defined as bleeding or perforation

  10 years

Study Arms (2)

High risk cohort

Patients having history of endoscopically confirmed ulcer bleeding, need long-term aspirin for cardiovascular or cerebrovascular prophylaxis and have a negative test for H. pylori based on histology

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• History of endoscopically confirmed ulcer bleeding
• Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis
• A negative test for H. pylori based on histology

You may not qualify if:

• Concomitant use of anti-ulcer drug, anticoagulant, non-aspirin NSAIDs or steroids
• Current or past H. pylori infection
• Previous acid-reduction gastric surgery
• Gastric outlet obstruction, erosive esophagitis, gastroesophageal varices
• Moribund or incurable cancers
• Average-risk cohort
• 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
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Study Officials

• Francis KL CHAN, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 1995
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

CN (1)