Cardiovascular DiseaseNCT00153725
Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
A study testing Aspirin and Pantoloc in people with Cardiovascular Disease and Cerebrovascular Disorders, run by Chinese University of Hong Kong at 3 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular Disease, Cerebrovascular Disorders
- What is being tested?
- Aspirin and Pantoloc
- How many people
- 156 participants
- Where
- 3 sitesChina
- Study dates
- Feb 2003to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Endoscopy Center, North District Hospital
Hong Kong
Endoscopy Center, Prince of Wales Hospital
Hong Kong
Endoscopy Center, United Christian Hospital
Hong Kong
About this study
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
Read the 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.
- Conditions
- Cardiovascular Disease, Cerebrovascular Disorders
- Being tested
- Aspirin and Pantoloc
- Medical subject headings
- Cardiovascular Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin and PantolocDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome:
Recurrent upper gastrointestinal bleeding within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 156 participants
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Joseph J Sung, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153725
- Sponsor's protocol ID
- PPA Study
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- Last updated
- 27 Oct 2006
- Results posted
- No
Publications
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. doi: 10.7326/0003-4819-152-1-201001050-00179. Epub 2009 Nov 30.
PubMed 19949136
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT00153725
- Acronym / sponsor ID
- PPA Study
- Conditions
- Cardiovascular Disease, Cerebrovascular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Sep 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin and Pantoloc | Drug | – |
Primary outcome
Primary Outcome:
Recurrent upper gastrointestinal bleeding within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2006.
- Derived from this study: PubMed 19949136Sung 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. doi: 10.7326/0003-4819-152-1-201001050-00179. Epub 2009 Nov 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J Sung, MD principal investigator
Chinese University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and Pantoloc in people with Cardiovascular Disease and Cerebrovascular Disorders, run by Chinese University of Hong Kong at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome:. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2006.