Back to resultsIntravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
Primary Purpose
Cardiovascular Disease, Cerebrovascular Disorders
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aspirin and Pantoloc
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease
Eligibility 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
Sites / Locations
- Endoscopy Center, North District Hospital
- Endoscopy Center, Prince of Wales Hospital
- Endoscopy Center, United Christian Hospital
Outcomes
Primary Outcome Measures
Primary Outcome:
Recurrent upper gastrointestinal bleeding within 30 days
Secondary Outcome Measures
Full Information
NCT ID
NCT00153725
First Posted
September 8, 2005
Last Updated
October 26, 2006
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00153725
Brief Title
Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Cerebrovascular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
156 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aspirin and Pantoloc
Primary Outcome Measure Information:
Title
Primary Outcome:
Title
Recurrent upper gastrointestinal bleeding within 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J Sung, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, North District Hospital
City
Hong Kong
Country
China
Facility Name
Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
Endoscopy Center, United Christian Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
19949136
Citation
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.
Results Reference
derived
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Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
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