Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153725
• Other study ID #: PPA Study
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: October 26, 2006
• Start date: February 2003
• Est. completion date: September 2006

Study information

• Verified date: October 2006
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Cerebrovascular Disorders

Intervention

Drug:
• Aspirin and Pantoloc

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome:
Primary	Recurrent upper gastrointestinal bleeding within 30 days