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CompletedNCT00683111Updated Jun 6, 2012

Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

A Phase 4 interventional study of esomeprazole 20 mg daily and famotidine 40 mg daily in Acute Coronary Syndrome and Acute Myocardial Infarction, sponsored by Ruttonjee Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-06.

Sponsored by Ruttonjee Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Coronary Syndrome
  • Acute Myocardial Infarction

Keywords

  • acute coronary syndrome
  • acute myocardial infarction
  • aspirin
  • clopidogrel
  • heparin
  • thrombolytic
  • famotidine
  • esomeprazole
03

In context

Acute Coronary Syndrome

1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 880 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Ruttonjee Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Active comparator
    1

    oral esomeprazole 20 mg daily

    Drug: esomeprazole 20 mg daily

  • Active comparator
    2

    oral famotidine 40mg daily

    Drug: famotidine 40 mg daily

Interventions

06

What researchers measure

Primary outcomes

  1. ulcer complication (bleeding/perforation/obstruction)

    Time frame: 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);

    Time frame: up to 12 months

07

Study locations

1 site
  • Ruttonjee Hospital
    Hong Kong, China
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2008
First posted
May 23, 2008
Start
Jul 2008
Primary completionActual
Dec 2011
CompletionActual
Dec 2011
Last update
Jun 6, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00683111
Lead sponsor
Ruttonjee Hospital
Responsible party
Fook-Hong Ng (SMO, Ruttonjee Hospital) — Principal investigator
First posted
May 23, 2008
Start date
Jul 2008
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jun 6, 2012

Study contacts

Fook Hong Ng, MBBS
principal investigator · Ruttonjee Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Esomeprazole · Famotidine

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