Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
Information source: Ruttonjee Hospital
ClinicalTrials.gov processed this data on August 23, 2015 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: Completed
Sponsored by: Ruttonjee Hospital Official(s) and/or principal investigator(s): Fook Hong Ng, MBBS, Principal Investigator, Affiliation: Ruttonjee Hospital
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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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
Ruttonjee Hospital, Hong Kong, China
Additional Information
Starting date: July 2008
Last updated: June 5, 2012
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