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Trial record 100 of 172 for:    "Heart Disease" | "Heparin"

Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

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. Identifier: NCT00683111
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):
Fook-Hong Ng, Ruttonjee Hospital

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00683111

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Ruttonjee Hospital
Hong Kong, China
Sponsors and Collaborators
Ruttonjee Hospital
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Principal Investigator: Fook Hong Ng, MBBS Ruttonjee Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Fook-Hong Ng, SMO, Ruttonjee Hospital Identifier: NCT00683111     History of Changes
Other Study ID Numbers: HKEC-2007-176
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by Fook-Hong Ng, Ruttonjee Hospital:
acute coronary syndrome
acute myocardial infarction
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
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