ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA

NCT01408186 | Completed Phase 3 DMC

• 1 other identifier: APH Study
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 8

Brief Summary

Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half of all cases of hospitalizations for peptic ulcer bleeding. Currently, ASA use has contributed to about one-third of the bleeding ulcers admitted to the investigators hospital that serves a local population of 1.5 million. In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a major dilemma. In another double-blind randomized trial, the investigators have shown that discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a significantly increased in mortality within 8 weeks. In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the dominant preventive strategy. Given the vast number of people taking ASA, however, it is only cost-effective to identify and treat those who are at high risk of ulcer bleeding and who have a strong indication for ASA use. Data from observational studies and randomized trials have consistently shown that PPIs are effective in reducing the risk of ulcer bleeding associated with ASA. Other potential preventive strategies include eradication of H. pylori infection, substitution of ASA for other non-aspirin anti-platelet drugs, and co-therapy with misoprostol or H2RAs.

Conditions

Upper Gastrointestinal Bleeding

Keywords

aspirin; PPI; H2RA

Outcome Measures

Primary Outcomes (1)

• recurrent non-variceal upper GI bleeding

  defined as hematemesis, melena or a decrease in hemoglobin of at least 2 g/dL with ulcers or bleeding erosions confirmed by endoscopy, and adjudicated by an independent committee

  12 months

Secondary Outcomes (3)

• lower GI bleeding

  12 Months

• atherothrombotic events

  12 months

• A composite of recurrent upper GI bleeding or recurrent endoscopic ulcers

  12 months

Study Arms (2)

Rabeprazole

ACTIVE COMPARATOR

Tablet 20mg daily for 12 months

Drug: Rabeprazole

Famotidine

ACTIVE COMPARATOR

Tablet 40mg daily for 12 months

Drug: Famotidine

Interventions

Rabeprazole DRUG

Rabeprazole 20 mg daily

Also known as: Pariet

Rabeprazole

Famotidine DRUG

Famotidine 40mg daily

Also known as: Pepcidine

Famotidine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable)
• Negative tests for H. pylori or successful eradication of H. pylori based on urease test or histology
• Expected regular use of ASA for the duration of the trial
• Age ≥ 18
• Written informed consent obtained

You may not qualify if:

• A history of gastric or duodenal surgery other than patch repair
• Severe erosive esophagitis (LA grade C or D)
• Gastric outlet obstruction
• Terminal illness
• Active malignancies

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (8)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Second Department of Internal Medicine, Shimane University Faculty of Medicine, Izumo, Japan

Izumo, Japan

Location

Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan

Kyoto, Japan

Location

Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan (Satellite hospital of Osaka City University)

Osaka, Japan

Location

Department of Gastroenterology, Osaka City University Graduate School of Medicine

Osaka, Japan

Location

Department of Gastroenterology, Takarazuka Municipal Hospital, Hyogo, Japan (Satellite hospital of Osaka City University)

Osaka, Japan

Location

Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Osaka, Japan

Osaka, Japan

Location

Department of Internal Medicine and Gastroenterology, Saga Medical School, Saga, Japan

Saga, Japan

Location

Related Publications (1)

• Chan FK, Kyaw M, Tanigawa T, Higuchi K, Fujimoto K, Cheong PK, Lee V, Kinoshita Y, Naito Y, Watanabe T, Ching JY, Lam K, Lo A, Chan H, Lui R, Tang RS, Sakata Y, Tse YK, Takeuchi T, Handa O, Nebiki H, Wu JC, Abe T, Mishiro T, Ng SC, Arakawa T. Similar Efficacy of Proton-Pump Inhibitors vs H2-Receptor Antagonists in Reducing Risk of Upper Gastrointestinal Bleeding or Ulcers in High-Risk Users of Low-Dose Aspirin. Gastroenterology. 2017 Jan;152(1):105-110.e1. doi: 10.1053/j.gastro.2016.09.006. Epub 2016 Sep 15.

  PMID: 27641510 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Rabeprazole; Famotidine

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• Francis KL Chan, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2016
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7); HK (1)