Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding - Full Text View

Sponsor:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00153725

Purpose

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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153725

Locations

China
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

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Joseph J Sung, MD

Chinese University of Hong Kong

More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Nov 30.

ClinicalTrials.gov Identifier:	NCT00153725 History of Changes
Other Study ID Numbers:	PPA Study
Study First Received:	September 8, 2005
Last Updated:	October 26, 2006
Health Authority:	Hong Kong: Department of Health

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
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012