Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding

This study has been completed.
Information provided by:
Chinese University of Hong Kong Identifier:
First received: September 8, 2005
Last updated: October 26, 2006
Last verified: October 2006

September 8, 2005
October 26, 2006
February 2003
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  • Primary Outcome:
  • Recurrent upper gastrointestinal bleeding within 30 days
Same as current
Complete list of historical versions of study NCT00153725 on Archive Site
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Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
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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

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.

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Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cardiovascular Disease
  • Cerebrovascular Disorders
Drug: Aspirin and Pantoloc
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2006
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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
18 Years to 90 Years
Contact information is only displayed when the study is recruiting subjects
PPA Study
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Chinese University of Hong Kong
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Principal Investigator: Joseph J Sung, MD Chinese University of Hong Kong
Chinese University of Hong Kong
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP