Status:
COMPLETED
Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
Lead Sponsor:
Ruttonjee Hospital
Conditions:
Acute Coronary Syndrome
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00683111
Start Date
July 1 2008
End Date
December 1 2011
Last Update
June 6 2012
Active Locations (1)
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1
Ruttonjee Hospital
Hong Kong, China