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A Cohort Study of Testing for Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding With Low-dose Aspirin (2NA3NANC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01591486
First received: April 25, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

Low-dose aspirin (ASA) has emerged as the most important cause of peptic ulcer bleeding worldwide. In western countries, ASA has overtaken non steroidal antiinflammatory drugs (NSAIDs) as a major cause of peptic ulcer bleeding in the elderly population [1,2]. Management of peptic ulcer bleeding in patients receiving ASA for cardiothrombotic diseases is a clinical dilemma. In a randomized trial of continuous versus interrupted ASA therapy after endoscopic treatment of peptic ulcer bleeding, patients who discontinued ASA had a 10-fold increased incidence of all-cause mortality compared to those who received continuous ASA therapy. On the other hand, patients receiving contiuous ASA therapy had a two-fold increased risk of early rebleeding [3]. Thus, preventing the occurrence of peptic ulcer bleeding in ASA users is important in reducing morbidity and mortality.

Given the uncertain clinical utility of Helicobacter Pylori (Hp) testing in ASA users, this prospective cohort study aims to determine whether testing for Hp will have any impact on the long-term incidence of ulcer bleeding in ASA users with high ulcer risk. The investigators hypothesise that among ASA users with Hp infection and ulcer bleeding, the long-term incidence of recurrent ulcer bleeding with ASA use will be low after eradication of Hp alone.


Condition
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Peptic Ulcer Bleeding

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Long-term Prospective Cohort Study of Testing for Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding With Low-dose Aspirin (2NA3NANC

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

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

Primary Outcome Measures:
  • The cumulative incidence of gastroduodenal ulcer bleeding [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    The cumulative incidence of gastroduodenal ulcer bleeding with ASA use in 10 years. Gastroduodenal ulcer bleeding is defined as haematemesis and/or melaena with gastroduodenal ulcers, or erosions with blood in the stomach confirmed by endoscopy, or a decrease in the haemoglobin level >2 g/dL in the presence of endoscopically proven ulcers.


Enrollment: 904
Study Start Date: January 1995
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hp-negative cohort

Hp-negative cohort

The second cohort consists of ASA users with ulcer bleeding but no current or past Hp infection, as evidenced by:

  1. negative rapid urease test
  2. negative histology for Hp infection on both initial and follow-up endoscopy
  3. negative serology test
  4. absence of intestinal metaplasia and atrophy on 4 random biopsies of the antrum and corpus

After ulcer healing, the Hp-negative cohort will receive enteric-coated ASA (<160 mg daily) without regular co-prescription of anti-ulcer drugs.
Hp-eradicated cohort
Hp-eradicated cohort This cohort consists of ASA users with ulcer bleeding and Hp infection who have healed ulcers and successful eradication of Hp on follow-up endoscopy. They will receive plain ASA (<160 mg daily) without co-prescription of anti-ulcer drugs.
Average-risk cohort
Average-risk cohort The third cohort consists of ASA-naive patients without a history of ulcer who attend the general outpatient clinic. They require long-term ASA for established cardiothrombotic diseases. They receive plain ASA (<160 mg daily) without co-prescription of anti-ulcer drugs. Hp status will not be determined in this cohort because Hp testing is not justified in average-risk asymptomatic patients.

  Show Detailed Description

  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

Consecutive users of ASA presented with upper gastrointestinal bleeding to the Endoscopy Centre of the Prince of Wales Hospital will be screened for eligibility. The Prince of Wales Hospital serves a local population of 1.5 million people in Hong Kong. All patients undergo endoscopy within 24 hours of hospitalisation to identify the source of bleeding, to secure haemostasis, and to determine their Hp status.

Criteria

Inclusion Criteria:

  1. Gastroduodenal ulcer bleeding confirmed by endoscopy
  2. Anticipated regular use of ASA for cardiothrombotic diseases

Exclusion Criteria:

  1. Uncontrolled bleeding requiring surgical intervention
  2. Previous gastric surgery except for a patch repair
  3. Gastroesophageal varices
  4. Gastric-outlet obstruction
  5. Gastroesophageal reflux disease requiring regular acid suppressive therapy
  6. Renal failure (defined by a serum creatinine level of more than 200 μmol per liter)
  7. Moribund conditions
  8. Active malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591486

Locations
China
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01591486     History of Changes
Other Study ID Numbers: 2NA3NANC
Study First Received: April 25, 2012
Last Updated: May 2, 2012
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Helicobacter pylori (Hp)
ASA users
peptic ulcer bleeding
cohorts

Additional relevant MeSH terms:
Bacterial Infections
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
 Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage

ClinicalTrials.gov processed this record on May 21, 2013