The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Index of microvascular resistance (IMR)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Positive plasma biomarkers of myocardial necrosis (cardiac troponin I [cTnI]).
- •Possible ischaemic symptoms include various combinations of chest, upper extremity, mandibular or epigastric discomfort (with exertion or at rest) or an ischaemic equivalent such as dyspnoea or fatigue.
- •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.
排除标准
- •Females of childbearing potential: pregnancy, breast-feeding.
- •History of hemorrhagic stroke, serious head injury within the last 3 months.
- •History of major surgery within the last 6 months.
- •History of PCI or CABG, or previous myocardial infarction.
- •Ongoing long term need for oral anticoagulants, antiplatelets, fibrinolytic, or antithrombotic agents, other than the study medication.
- •Having any implanted pacemaker or cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy defibrillators (CRT-D).
- •Present with cardiogenic shock, 3rd degree atrioventricular (AV) block, complex anatomical coronary condition.
- •Planned for a staged PCI within 30 days after the current PCI
- •Inadequate liver function
- •CRUSADE bleeding score of > 30
- •Known or suspected allergy to other lumbrokinase products.
- •Prior experience with DLBS1033 or other oral lumbrokinase products.
- •Clinical evidence of malignancies with survival period < 1 year.
- •Any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could jeopardize patient's safety or interfere with trial participation or trial evaluation.
- •Subjects enrolled in other interventional protocol within 30 days prior to Screening
- •Any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could jeopardize patient's safety or interfere with trial participation or trial evaluation.
研究组 & 干预措施
DLBS1033
DLBS1033 enteric-coated tablet is administered at the dose of 980 mg (two tablets@490 mg) three times daily, everyday for four weeks of study period
干预措施: DLBS1033 (Drug)
DLBS1033
DLBS1033 enteric-coated tablet is administered at the dose of 980 mg (two tablets@490 mg) three times daily, everyday for four weeks of study period
干预措施: Standard therapy (Drug)
Placebo
Placebo is administered two tablets three times daily, everyday for four weeks of study period
干预措施: Placebo (Drug)
Placebo
Placebo is administered two tablets three times daily, everyday for four weeks of study period
干预措施: Standard therapy (Drug)
结局指标
主要结局
Index of microvascular resistance (IMR)
时间窗: Week 4
Improvement in the index of microvascular resistance (IMR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.
次要结局
- Renal function(Week 0 and 4)
- Improvement in fractional flow reserve (FFR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire(Week 4)
- Liver function(Week 0 and 4)
- Routine hematology (Hematocrit)(Week 0, 2 and 4)
- LV function(Week 4)
- Routine hematology (Hemoglobin)(Week 0, 2 and 4)
- Haemostasis parameter (International Normalized Ratio (INR))(Week 0, 2, and 4)
- Adverse event(Week 0 - 4)
- Routine hematology(Week 0 and 4)
- Haemostasis parameter (Prothrombin time (PT))(Week 0, 2, and 4)