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Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding

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ClinicalTrials.gov Identifier: NCT00153725
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 27, 2006
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Cerebrovascular Disorders Drug: Aspirin and Pantoloc Not Applicable

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 Type : Interventional  (Clinical Trial)
Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2003
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources




Primary Outcome Measures :
  1. Primary Outcome:
  2. Recurrent upper gastrointestinal bleeding within 30 days


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153725


Locations
China
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
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Joseph J Sung, MD Chinese University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00153725     History of Changes
Other Study ID Numbers: PPA Study
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 27, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics