Acute Non-ST Elevation Myocardial Infarction Clinical Trial
Official title:
The Role of DLBS1033 in The Management of Acute Non-ST Elevation of Myocardial Infarction (NSTEMI) Without Early Coronary Revascularization
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without early coronary revascularization. It is hypothesized that the combination of DLBS1033 with aspirin and clopidogrel will result in greater reduction of infarct size in comparison with that of aspirin and clopidogrel alone.
After diagnosed NSTEMI, patient is hospitalized and given medications according to the
standard management of acute NSTEMI, including anticoagulant low molecular weight heparin.
Eligible subjects are then randomized to receive either DLBS1033 at a dose of 490 mg three
times daily or its placebo in addition to clopidogrel 75 mg once daily and aspirin 160 mg
once daily for an 8-week course of therapy. Afterwards, the administration of DLBS1033 and
its placebo are stopped, while the dual antiplatelet therapy (aspirin and clopidogrel)
remains for another 16 weeks at the same dose regimen as the previous.
Clinical and laboratory examinations to evaluate the investigational drug's efficacy and
safety are performed at baseline, week 4, week 8, and week 24. To guard the safety of the
study subjects, haemostasis parameters, hematology parameters, and CRUSADE bleeding score
are evaluated every two-week-interval over the first eight weeks of treatment.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment