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Completed

NCT Number: NCT00153725

Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding

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

Completed

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopy Center, North District Hospital, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin and Pantoloc

Drug

Primary outcomes

  1. Primary Outcome:

  2. Recurrent upper gastrointestinal bleeding within 30 days

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Oct 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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