Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease - Full Text View

Sponsor:	Ruttonjee Hospital
Information provided by:	Ruttonjee Hospital
ClinicalTrials.gov Identifier:	NCT00683111

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Blood Thinners Gastrointestinal Bleeding Heart Attack Heart Diseases

Drug Information available for: Omeprazole Famotidine Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Ruttonjee Hospital:

Primary Outcome Measures:

ulcer complication (bleeding/perforation/obstruction) [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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
1: Active Comparator 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
2: Active Comparator 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683111

Contacts

Contact: Fook Hong Ng, MB, BS

852-2291-1743

ngfhong@hkucc.hku.hk

Locations

China
Ruttonjee Hospital	Recruiting
Hong Kong, China
Contact: Fook Hong Ng, MB BS 85222911743
Principal Investigator: Fook Hong Ng, MB BS

Sponsors and Collaborators

Ruttonjee Hospital

Investigators

Principal Investigator:

Fook Hong Ng, MBBS

Ruttonjee Hospital

More Information

No publications provided

Responsible Party:	Ruttonjee Hospital ( Dr Fook Hong Ng )
Study ID Numbers:	HKEC-2007-176
Study First Received:	May 21, 2008
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00683111 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Ruttonjee Hospital:

acute coronary syndrome
acute myocardial infarction
aspirin
clopidogrel

heparin
thrombolytic
famotidine
esomeprazole

Additional relevant MeSH terms:

Neurotransmitter Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Gastrointestinal Agents
Vascular Diseases
Histamine Agents
Omeprazole
Enzyme Inhibitors
Ischemia
Histamine H2 Antagonists

Pharmacologic Actions
Necrosis
Pathologic Processes
Histamine Antagonists
Famotidine
Therapeutic Uses
Acute Coronary Syndrome
Anti-Ulcer Agents
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on March 18, 2010