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Sponsored by: |
Ruttonjee Hospital |
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Information provided by: | Ruttonjee Hospital |
ClinicalTrials.gov Identifier: | NCT00683111 |
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 |
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Acute Coronary Syndrome Acute Myocardial Infarction |
Drug: esomeprazole 20 mg daily Drug: famotidine 40 mg daily |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction |
Estimated Enrollment: | 500 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
oral esomeprazole 20 mg daily
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Drug: esomeprazole 20 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
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2: Active Comparator
oral famotidine 40mg daily
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Drug: famotidine 40 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fook Hong Ng, MB, BS | 852-2291-1743 | ngfhong@hkucc.hku.hk |
China | |
Ruttonjee Hospital | Recruiting |
Hong Kong, China | |
Contact: Fook Hong Ng, MB BS 85222911743 | |
Principal Investigator: Fook Hong Ng, MB BS |
Principal Investigator: | Fook Hong Ng, MBBS | Ruttonjee Hospital |
Responsible Party: | Ruttonjee Hospital ( Dr Fook Hong Ng ) |
Study ID Numbers: | HKEC-2007-176 |
Study First Received: | May 21, 2008 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00683111 History of Changes |
Health Authority: | Hong Kong: Ethics Committee |
acute coronary syndrome acute myocardial infarction aspirin clopidogrel |
heparin thrombolytic famotidine esomeprazole |
Neurotransmitter Agents Heart Diseases Myocardial Ischemia Ulcer Gastrointestinal Hemorrhage Vascular Diseases Omeprazole Fibrinolytic Agents Ischemia Hemorrhage Histamine H2 Antagonists Histamine |
Calcium heparin Necrosis Histamine Antagonists Famotidine Aspirin Clopidogrel Acute Coronary Syndrome Histamine phosphate Infarction Heparin Myocardial Infarction |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Omeprazole Necrosis Pathologic Processes Famotidine Syndrome Therapeutic Uses Anti-Ulcer Agents Cardiovascular Diseases Myocardial Infarction |
Disease Heart Diseases Vascular Diseases Gastrointestinal Agents Histamine Agents Enzyme Inhibitors Ischemia Pharmacologic Actions Histamine H2 Antagonists Histamine Antagonists Acute Coronary Syndrome Infarction |