Acute Coronary SyndromePhase 4NCT00683111
Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
A Phase 4 study testing esomeprazole 20 mg daily and famotidine 40 mg daily in people with Acute Coronary Syndrome and Acute Myocardial Infarction, run by Ruttonjee Hospital at 1 site in China.
Trial summary
Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Acute Myocardial Infarction
- What is being tested?
- esomeprazole 20 mg daily and famotidine 40 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Dec 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)
Who cannot join
- known active peptic ulcer disease or gastrointestinal within 8 wk
- known iron deficiency anemia with Hb < 10 gm/dl
- mechanical ventilation
- active cancer, liver cirrhosis, end-stage renal failure
- life expectancy < 1 yr
- known allergic to aspirin, clopidogrel, enoxaparin famotidine or esomeprazole
Show all 10Show fewer
- pregnancy, lactation, child-bearing potential in the absence of contraception,
- co-prescription of NSAID, corticosteroid, or warfarin
- non-oral feeding or impaired GI absorption e.g. vomiting
- already on proton pump inhibitor for > 1 day or another clinical trial drug for ulcer disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly prescribed. There has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.
- Being tested
- esomeprazole 20 mg daily, famotidine 40 mg daily
- Keywords
- acute coronary syndrome, acute myocardial infarction, aspirin, clopidogrel, heparin, thrombolytic, famotidine, esomeprazole
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole 20 mg dailyDrug
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
famotidine 40 mg dailyDrug
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | oral esomeprazole 20 mg daily Receives: Drug: esomeprazole 20 mg daily |
| 2 | Active comparator | oral famotidine 40mg daily Receives: Drug: famotidine 40 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer complication (bleeding/perforation/obstruction)
Measured: up to 12 months
Secondary outcomes (1)
Termination of anti-ischemic drug due to ulcer complications; TIMI severity of GI bleeding; Major adverse cardiac event (composite of death from CV causes, recurrent nonfatal MI, or stroke);
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionDec 2011
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 Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruttonjee Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fook-Hong Ng, Ruttonjee Hospital
- Investigators
- Fook Hong Ng, MBBS, Principal investigator, Ruttonjee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683111
- Sponsor's protocol ID
- HKEC-2007-176
- Status last verified
- Jun 2012
- First submitted
- 21 May 2008
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ng FH, Tunggal P, Chu WM, Lam KF, Li A, Chan K, Lau YK, Kng C, Keung KK, Kwan A, Wong BC. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012 Mar;107(3):389-96. doi: 10.1038/ajg.2011.385. Epub 2011 Nov 22.
PubMed 22108447
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00683111
- Acronym / sponsor ID
- HKEC-2007-176
- Keywords
- acute coronary syndrome, acute myocardial infarction, aspirin, clopidogrel, heparin, thrombolytic, famotidine, esomeprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ruttonjee HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 May 2008 (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.
Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly prescribed. There has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: esomeprazole 20 mg dailyoral esomeprazole 20 mg daily |
| 2 | Active comparator | Drug: famotidine 40 mg dailyoral famotidine 40mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)
Key exclusion criteria (10 listed)
- known active peptic ulcer disease or gastrointestinal within 8 wk
- known iron deficiency anemia with Hb < 10 gm/dl
- mechanical ventilation
- active cancer, liver cirrhosis, end-stage renal failure
- life expectancy < 1 yr
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 |
|---|---|---|
| esomeprazole 20 mg dailyoral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months | Drug | 1 |
| famotidine 40 mg dailyoral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months | Drug | 2 |
Primary outcome
ulcer complication (bleeding/perforation/obstruction)
Time frame: up to 12 months
1 secondary outcome
Termination of anti-ischemic drug due to ulcer complications; TIMI severity of GI bleeding; Major adverse cardiac event (composite of death from CV causes, recurrent nonfatal MI, or stroke);
Time frame: up to 12 months
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 6 Jun 2012.
- Derived from this study: PubMed 22108447Ng FH, Tunggal P, Chu WM, Lam KF, Li A, Chan K, Lau YK, Kng C, Keung KK, Kwan A, Wong BC. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012 Mar;107(3):389-96. doi: 10.1038/ajg.2011.385. Epub 2011 Nov 22.
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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.
Fook Hong Ng, MBBS principal investigator
Ruttonjee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole 20 mg daily and famotidine 40 mg daily in people with Acute Coronary Syndrome and Acute Myocardial Infarction, run by Ruttonjee Hospital at 1 site 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 1 inclusion and 10 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ulcer complication (bleeding/perforation/obstruction) (time frame: up to 12 months). 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 NCT00683111, 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 6 Jun 2012.