Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding

Not Applicable

Completed

• Conditions: Cerebrovascular Disorders; Cardiovascular Disease

• Registration Number: NCT00153725
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2006-09
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-26
• Last Update Posted: 2006-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Outcome:
Recurrent upper gastrointestinal bleeding within 30 days

Trial Locations

Locations (3)

Endoscopy Center, North District Hospital; 🇨🇳 Hong Kong, China

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong, China

Endoscopy Center, United Christian Hospital; 🇨🇳 Hong Kong, China