Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00153725
• Collaborator: (none)
• Enrollment: 156
• Locations: 3
• Duration (Months): 43
• Patients Per Site: 52
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2003
• Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. Primary Outcome: []

2. Recurrent upper gastrointestinal bleeding within 30 days []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Endoscopy Center, North District Hospital	Hong Kong		China
2	Endoscopy Center, Prince of Wales Hospital	Hong Kong		China
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00153725
• Other Study ID Numbers: PPA Study
• First Posted: Sep 12, 2005
• Last Update Posted: Oct 27, 2006
• Last Verified: Oct 1, 2006

• Additional relevant MeSH terms: Cerebrovascular Disorders; Cardiovascular Diseases; Aspirin

Study Results

No Results Posted as of Oct 27, 2006