Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruttonjee Hospital
• Treatments: Esomeprazole; Famotidine

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