Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
Information source: Chinese University of Hong Kong
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Disease; Cerebrovascular Disorders
Intervention: Aspirin and Pantoloc (Drug)
Phase: N/A
Status: Completed
Sponsored by: Chinese University of Hong Kong Official(s) and/or principal investigator(s):
Joseph J Sung, MD, Principal Investigator, Affiliation: Chinese University of Hong Kong
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
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Primary Outcome:Recurrent upper gastrointestinal bleeding within 30 days
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Endoscopy Center, Prince of Wales Hospital, Hong Kong, China
Endoscopy Center, North District Hospital, Hong Kong, China
Endoscopy Center, United Christian Hospital, Hong Kong, China
Additional Information
Starting date: February 2003
Ending date: September 2006
Last updated: October 26, 2006
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