Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
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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 |
- Primary Outcome:
- Recurrent upper gastrointestinal bleeding within 30 days
| Estimated Enrollment: | 156 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | September 2006 |
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 |
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| 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 | |
| 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):
| 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 May 16, 2013