Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
Information source: Ruttonjee Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome; Acute Myocardial Infarction
Intervention: esomeprazole 20 mg daily (Drug); famotidine 40 mg daily (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ruttonjee Hospital Official(s) and/or principal investigator(s):
Fook Hong Ng, MBBS, Principal Investigator, Affiliation: Ruttonjee Hospital
Overall contact:
Fook Hong Ng, MB, BS, Phone: 852-2291-1743, Email: ngfhong@hkucc.hku.hk
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.
Clinical Details
Official title: Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Primary outcome: ulcer complication (bleeding/perforation/obstruction)
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);
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients admitted for acute coronary syndrome or acute myocardial infarction
requiring active treatment with aspirin clopidogrel and (enoxaparin or
thrombolytics.)
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
Locations and Contacts
Fook Hong Ng, MB, BS, Phone: 852-2291-1743, Email: ngfhong@hkucc.hku.hk
Ruttonjee Hospital, Hong Kong, China; Recruiting
Fook Hong Ng, MB BS, Phone: 85222911743
Fook Hong Ng, MB BS, Principal Investigator
Additional Information
Starting date: July 2008
Ending date: December 2011
Last updated: July 11, 2009
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