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OpenTrials
Completed

NCT Number: NCT00683111

Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

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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Key information

Conditions

Acute Coronary Syndrome Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruttonjee Hospital

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

esomeprazole 20 mg daily

Drug

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

famotidine 40 mg daily

Drug

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

Primary outcomes

  1. ulcer complication (bleeding/perforation/obstruction)

    Time frame: up to 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ruttonjee Hospital

Other

Registry information

Official study title

Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 23, 2008
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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