Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

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

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • oral esomeprazole 20 mg daily
• Active Comparator: 2
  • oral famotidine 40mg daily

Primary Measures

• ulcer complication (bleeding/perforation/obstruction)
  • Time Frame: up to 12 months
    Safety Issue?: Yes

Secondary Measures

• 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);
  • Time Frame: up to 12 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ruttonjee Hospital Other

Overall Clinical Trial Officials and Contacts

Fook Hong Ng, MBBS Principal Investigator Ruttonjee Hospital  

Overall Contact: Fook Hong Ng, MB, BS 852-2291-1743 ngfhong@hkucc.hku.hk

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683111

Study ID Number: HKEC-2007-176

ClinicalTrials.gov Identifier: NCT00683111

Health Authority: Hong Kong: Ethics Committee