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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

Page last updated: August 23, 2015

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