NCT02495012Unknown2 期
A Multi-centered, Randomized, Double-blinded, Placebo-Parallel Controlled Phase IIb Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin Injection for the Treatment of Patients With ST Segment Elevation Myocardial Infarction (STEMI) Before Receiving PCI Therapy.
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- ratio of TMPG grade 2 and grade 3
研究概览
简要总结
A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
详细描述
Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years;
- •Fulfill the standard of direct PCI: ST Segment Elevation Myocardial Infarction occurred < 12 hours (ST Segment Elevation or New Left Bundle Branch Block (LBBB), combined myocardial ischemia chest pain medical history or the dynamic change of cardiac marker (troponin and/or CK-MB);
- •Patients who will receive PCI and suitable for angioplasty and stent placement;
- •Patients, or their family or guardian give signed informed consent forms.
排除标准
- •Patients with weight < 50kg;
- •Patients with severe hepatic or renal dysfunction, alanine aminotransferase (ALT) exceeds 3 times the normal maximum reference level, creatinine clearance level < 30ml/min or serum creatinine ≥ 200μmol/L or ≥2.5mg/dl;
- •Patients with severe hemodynamic instability;
- •Patients who will receive 2 times or more PCI treatment;
- •Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
- •Patients with untreated hypertension (SBP > 180mmHg or DBP > 110mmHg) or hypotension shock (SBP < 90mmHg);
- •Patients received GPIIb/IIIa receptor antagonists and/or thrombolytic therapy before randomization;
- •Used eptifibatide and tirofiban in the past 12 hours before the randomization;
- •Used abxicimab in the past 7 days before the randomization;
- •Have received thrombolytic therapy before the randomization;
- •Patients who need a long-term treatment of clopidogrel;
- •Patients who have received enoxaparin sodium injection before the surgery;
- •Patients who have hemorrhage risk:
- •Suffered from ischemic stroke or transient ischemic attack (TIA) in the past 12 months;
- •Suffered from hemorrhage stroke, or other life-long neuronal dysfunction;
- •Suffered from tumor, arteriovenous malformation in brain and aneurysms;
- •Suffered from traumatic brain injury in the past 3 months, or received major surgery;
- •Received percutaneous coronary intervention (PCI) in the past 6 months;
- •Have received coronary artery bypass graft therapy (CABG);
- •Receiving long-term oral anticoagulants therapy;
- •Suffered from active peptic ulcer, urinary and reproductive tract hemorrhage, or other active hemorrhage.
- •Patients with coagulation disorder:
- •Known as international normalized ratio > 2*;
- •Patients with coagulation abnormalities or other hemorrhagic tendency (including inherited hemorrhagic diseases, e.g. Von Willebrand disease or hemophilia; acquired hemorrhagic diseases; and other clinically identified hemorrhagic diseases with unsolved rationale);
- •Hematology test shows platelet count < 100x109mm3/L, or hemoglobin < 100g/L;
- •Recorded clopidogrel-related thrombocytopenia or agranulocytosis;
- •Life expectancy < 1 year;
- •Patients who have implemented with pacemaker, and contraindicated to MRI examination;
- •Patients who are allergic constitution or allergic to any component of aspirin, clopidogrel, creatinine, antiplatelet thrombolysin and investigational product;
- •Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures;
- •Patients who are participating or will be participating in other clinical trials;
- •Patients who have participated in clinical trials of antiplatelet thrombolysin or other related trials;
- •Patients who are not suitable for participating in this clinical trial according to the investigator's judgment, including who are unable or unwilling to follow the protocol;
- •Patients who participated in other clinical trials in the past 3 months.
研究组 & 干预措施
control
Placebo Comparator
5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours
干预措施: placebo (Drug)
treatment
Active Comparator
5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours
干预措施: Anfibatide (Drug)
结局指标
主要结局
ratio of TMPG grade 2 and grade 3
时间窗: within 24 hours
After PCI, TMPG grade will be evaluated and
次要结局
- inhibition rate of platelet aggregation and GP1b receptor combination rate(48 hours)
- Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy(24 hours)
- The depression level of ST segment from right after the PCI therapy to 2 hours later(within 24 hours)
- Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively(72 hours)
- (6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)(5 days)
- (7) While surgery and hospitalization, follow the ratio and dose as suggested by the surgeon in case of emergency use of GP IIb/IIIa receptor antagonist or other antiplatelet drug(5 days)
- (8) Clinical endpoint 30 days after surgery (caused by death, non-fatal myocardial infarction reissue, blood clot formation after stent implantation, non-fatal stroke, target lesion revascularization reissue) and the analysis of the causes(30days)
- Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)(30days)
- Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy(24 hours)
研究者
研究点 (1)
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