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This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the study.
Full description
STE-ACS patients who undergo intermediate-delayed (> 3 hours after the onset of the STEMI) primary PCI will be enrolled in the study. Before the intervention, they will be given standard medication for PCI.
Right after PCI, all eligible subjects will be assessed for microvascular perfusion, using a pressure-temperature sensor-tipped coronary guidewire.
The day after, in addition to the dual antiplatelet therapy, i.e. 80 mg aspirin once daily and clopidogrel 75 mg once daily, DLBS1033 at a dose of 980 mg three times daily or its placebo will be given to the subjects for 4 weeks.
Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at Baseline (right after subjects undergo the primary PCI) and at the End of study (week 4th of DLBS1033 therapy).
Enrollment
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Inclusion and exclusion criteria
KEY Inclusion Criteria:
Signed informed consent.
Men or women of 30-75 years of age.
Evidence of acute ST elevation myocardial infarction (STEMI) at screening, as confirmed by ECG presentation of STEMI: new ST elevation at the J point in two contiguous leads with the cut-points: ≥ 0.1 mV in all leads other than leads V2-V3, where the following cut-points apply: ≥ 0.2 mV in men ≥ 40 years, ≥ 0.25 mV in men < 40 years, or ≥ 0.15 mV in women; or new or presumably new left bundle-branch block (LBBB); and with at least one of the following:
The onset of the STEMI is > 3 hours before undergoing the primary PCI.
Therapy with study medication can be started within 24 hours after primary PCI.
Able to take oral medication.
KEY Exclusion Criteria:
Primary purpose
Allocation
Interventional model
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23 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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