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

NCT01278550 | Completed

• 1 other identifier: 2NANC
• Study Type: observational
• Target: 503
• 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). 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.

Conditions

Ulcer Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Ulcer complications, defined as bleeding or perforation

  10 years

Study Arms (2)

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

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:

• 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

You may not qualify if:

• 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
• 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 (sar), 852, 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 18, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 1995
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

CN (1)