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Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683111
First Posted: May 23, 2008
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fook-Hong Ng, Ruttonjee Hospital
  Purpose
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.

Condition Intervention Phase
Acute Coronary Syndrome Acute Myocardial Infarction Drug: esomeprazole 20 mg daily Drug: famotidine 40 mg daily Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Fook-Hong Ng, Ruttonjee Hospital:

Primary Outcome Measures:
  • ulcer complication (bleeding/perforation/obstruction) [ Time Frame: up to 12 months ]

Secondary Outcome 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 ]

Estimated Enrollment: 500
Study Start Date: July 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
oral esomeprazole 20 mg daily
Drug: esomeprazole 20 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
Active Comparator: 2
oral famotidine 40mg daily
Drug: famotidine 40 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683111


Locations
China
Ruttonjee Hospital
Hong Kong, China
Sponsors and Collaborators
Ruttonjee Hospital
Investigators
Principal Investigator: Fook Hong Ng, MBBS Ruttonjee Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fook-Hong Ng, SMO, Ruttonjee Hospital
ClinicalTrials.gov Identifier: NCT00683111     History of Changes
Other Study ID Numbers: HKEC-2007-176
First Submitted: May 21, 2008
First Posted: May 23, 2008
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Fook-Hong Ng, Ruttonjee Hospital:
acute coronary syndrome
acute myocardial infarction
aspirin
clopidogrel
heparin
thrombolytic
famotidine
esomeprazole

Additional relevant MeSH terms:
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Esomeprazole
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs