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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Standard therapy which consists of: aspirin enteric-coated tablet 1 x 80 mg and clopidogrel film-coated tablet 1 x 75 mg daily for four weeks will be given to both arms.
Binawaluya Cardiac Hospital
Jakarta, Indonesia
Index of microvascular resistance (IMR)
Improvement in the index of microvascular resistance (IMR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.
Time frame: Week 4
Improvement in fractional flow reserve (FFR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire
Improvement in fractional flow reserve (FFR) from baseline and to Week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.
Time frame: Week 4
LV function
Improvement in several parameters of left ventricular (LV) function \[EF, ESV, EDV\], from baseline and to Week 4th of treatment will be measured by 2D echocardiography.
Time frame: Week 4
Routine hematology
Routine hematology, including: RBC, WBC, and platelet count, will be measured at baseline and week 4th of treatment.
Time frame: Week 0 and 4
Routine hematology (Hemoglobin)
Hemoglobin will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.
Time frame: Week 0, 2 and 4
Routine hematology (Hematocrit)
Hematocrit will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.
Time frame: Week 0, 2 and 4
Liver function
Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), alkaline phosphatase, and total bilirubin.
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Time frame: Week 0 and 4
Renal function
Renal function measured includes: serum creatinine and BUN.
Time frame: Week 0 and 4
Haemostasis parameter (Prothrombin time (PT))
Prothrombin time (PT) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.
Time frame: Week 0, 2, and 4
Haemostasis parameter (International Normalized Ratio (INR))
International Normalized Ratio (INR) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.
Time frame: Week 0, 2, and 4
Adverse event
Adverse events (especially major and minor bleeding) are observed and carefully evaluated along the course of the study.
Time frame: Week 0 - 4