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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
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 Intervention
Cardiovascular Disease Cerebrovascular Disorders Drug: Aspirin and Pantoloc

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Primary Outcome:
  • Recurrent upper gastrointestinal bleeding within 30 days

Estimated Enrollment: 156
Study Start Date: February 2003
Estimated Study Completion Date: September 2006
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.

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00153725

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
Principal Investigator: Joseph J Sung, MD Chinese University of Hong Kong
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00153725     History of Changes
Other Study ID Numbers: PPA Study
Study First Received: September 8, 2005
Last Updated: October 26, 2006

Additional relevant MeSH terms:
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on August 18, 2017