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Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding

NCT ID: NCT00153725

Last Updated: 2006-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-09-30

Brief Summary

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The aim of the study is to investigate whether intravenous infusion of pantoprazole (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute ulcer bleeding and continue to use aspirin

Detailed Description

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Aspirin is an effective treatment for acute stroke and heart attack. However, aspirin also induces ulcer and provokes acute ulcer bleeding. Thus, aspirin is often withheld in acute ulcer bleeding but this precipitate recurrent stroke or heart attack. We previously showed that intravenous infusion of a potent acid suppressant substantially reduced the incidence of recurrent ulcer bleeding in patients who withheld aspirin. The aim of this study is to investigate whether intravenous infusion of an acid suppressant (Pantoprazole) is effective in preventing recurrent ulcer bleeding with continuous use of aspirin.

Conditions

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Cardiovascular Disease Cerebrovascular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aspirin and Pantoloc

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients received daily anti-platelet therapy for vascular prophylaxis before admission and will continue need to do so
* Patinets with bleeding peptic ulcers;ulcer actively bleeding or with SRH (Forrest I, IIa and IIb ulcers)
* Endoscopic haemostasis achieved

Exclusion Criteria

* Presence of ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention.
* Concomitant use of anticoagulant, NSAIDs or steroid
* Pending to undergo cardiac interventions that need double anti-platelet agent
* Pregnancy
* Terminal illness, or cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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Joseph J Sung, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Endoscopy Center, North District Hospital

Hong Kong, , China

Site Status

Endoscopy Center, Prince of Wales Hospital

Hong Kong, , China

Site Status

Endoscopy Center, United Christian Hospital

Hong Kong, , China

Site Status

Countries

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China

References

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Sung JJ, Lau JY, Ching JY, Wu JC, Lee YT, Chiu PW, Leung VK, Wong VW, Chan FK. Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2010 Jan 5;152(1):1-9. doi: 10.7326/0003-4819-152-1-201001050-00179. Epub 2009 Nov 30.

Reference Type DERIVED
PMID: 19949136 (View on PubMed)

Other Identifiers

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PPA Study

Identifier Type: -

Identifier Source: org_study_id