Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

oral esomeprazole 20 mg daily

Group Type ACTIVE_COMPARATOR

esomeprazole 20 mg daily

Intervention Type DRUG

oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months

2

oral famotidine 40mg daily

Group Type ACTIVE_COMPARATOR

famotidine 40 mg daily

Intervention Type DRUG

oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months

Interventions

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esomeprazole 20 mg daily

oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months

Intervention Type DRUG

famotidine 40 mg daily

oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No