Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Study Overview
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Brief Summary
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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.

Official Title
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Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction

Conditions
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Acute Coronary Syndrome, Acute Myocardial Infarction

Intervention / Treatment
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* Drug: esomeprazole 20 mg daily
* Drug: famotidine 40 mg daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>oral esomeprazole 20 mg daily | Drug: esomeprazole 20 mg daily<br>* oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months<br>|
| Active Comparator: 2<br>oral famotidine 40mg daily | Drug: famotidine 40 mg daily<br>* oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer complication (bleeding/perforation/obstruction) |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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); |  | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, acute coronary syndrome, acute myocardial infarction, clopidogrel, heparin, thrombolytic, famotidine, esomeprazole