Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Ruttonjee Hospital

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Acute Myocardial Infarction

Treatments

Drug: esomeprazole 20 mg daily

Drug: famotidine 40 mg daily

Study type

Interventional

Funder types

Other

Identifiers

NCT00683111

HKEC-2007-176

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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