Acute Coronary Syndrome, Acute Myocardial Infarction
Conditions
Keywords
acute coronary syndrome, acute myocardial infarction, aspirin, clopidogrel, heparin, thrombolytic, famotidine, esomeprazole
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.
Interventions
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
Sponsors
Ruttonjee Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ulcer complication (bleeding/perforation/obstruction) | up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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); | up to 12 months |
Countries
China
Outcome results
None listed