NCT01585259已完成1 期
A Multi-center, Randomized, Double-blind, Multi-dose Group, Parallel Group and Placebo Controlled Phase Ib-IIa Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin for Injection for the Treatment of Patients With Non-ST Segment Elevation Myocardial Infarction (NSTEMI).
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Platelet aggregation
研究概览
简要总结
Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction patients
详细描述
- This study is a phase Ib-IIa exploratory study to observe the safety of Antiplatelet Thrombolysin for Injection for the treatment of non-ST segment myocardial infarction (NSTEMI) patients and preliminarily evaluate the efficacy of different doses, providing the theoretical basis of the phase II and III clinical study protocol.
- To investigate the pharmacokinetics of different doses.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years;
- •Laboratory tests show increase of the markers of myocardial damage (CK-MB,CTnI), or reduction after increase, with at least one values exceeding the 99th percentile of the upper limit of the reference value;
- •Ischemia symptoms (ischemic chest pain lasts for over 15 minutes, little release after taking nitroglycerin sublingually) or a new myocardial ischemia on electrocardiogram(ECG), i.e. a new ST-T variation (a new or transient depression of ST segment by over 0.1mV, or T-wave inversion≥0.2mV);
- •Patients receive PCI after coronary angiography;
- •Patients, or their family or guardian give signed informed consent forms.
排除标准
- •Patients with severe unstable hemodynamics who should receive urgent PCI;
- •Patients with untreated hypertension (SBP>180 mmHg or DBP >110mmHg) and hypotension shock (SBP<90mmHg/80mmHg for over 30min);
- •Investigator considers patients need to use GPIIb/IIIa receptor antagonists during the study period;
- •After coronary angiography, the number of stenosed vessels >2；lesions in left main branch, severe calcification and artery graft lesions;
- •Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
- •Patients with malignant arrhythmia, e.g. the third-degree atrioventricular block, ventricular tachycardia or fibrillation ventricular;
- •Patients with severe hepatic or renal dysfunction, with serum aspartate transaminase(AST) and alanine transaminase (ALT) exceeding 1.5 times the upper limit of reference values, creatinine clearance <30ml/min or serum creatinine ≥200μmol/L or 2.5mg/dl;
- •Patients who have received PCI in the past six months;
- •Patients who have received coronary artery bypass grafting (CABG) previously;
- •Patients who have received invasive operation in the past 3 months;
- •Patients who have suffered from ischemic stroke or transient ischemic attack (TIA) in the past 6 months, or patients with past history of hemorrhagic stroke;
- •Patients who need a long-term treatment of oral anticoagulants (such as warfarin);
- •Patients with active peptic ulcer, or other diseases of hemorrhagic tendency;
- •Patients with disease of coagulation disorder;
- •Hematology test shows platelet count <100,000mm3,or hemoglobin<100g/L;
- •Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures;
- •Patients with an allergic constitution;
- •Patients who is participating in other clinical trials;
- •Patients who do not give a signed informed consent forms;
- •Patients who are not suitable to enroll in the trial according to the investigator's judgement.
研究组 & 干预措施
Anfibatide
Active Comparator
Bolus injection will be finished in 5 minutes immediately when the guidewire passes through the first stenosed vessel; bolus injection of different doses+0.002IU/kg/h intravenous infusion for 48h
干预措施: Anfibatide (Drug)
Placebo
Placebo Comparator
Bolus injection will be finished in 5 minutes immediately when the guidewire passes through the first stenosed vessel; bolus injection of different doses+0.002IU/kg/h intravenous infusion for 48h
干预措施: Placebo (Drug)
结局指标
主要结局
Platelet aggregation
时间窗: up to 48 hours
The inhibition of ristocetin-induced platelet aggregation as measured by whole blood impedance aggregometr in vitro.
Bleeding events
时间窗: Day 0 to day 30
Bleeding events classified according to the Bleeding Academic Research Consortium (BARC) .
次要结局
- Thrombosis formation(48 hours after infusion during operation)
- Mortality(30 days after treatment)
- Safety Endpoints(Day 0 to day 30)
- Thrombolysis in myocardial infraction (TIMI)(day 0)
- Corrected TIMI frame count（CTFC）(day 0)
- TIMI myocardial perfusion grade （TMBG）(day 0)
研究者
研究点 (1)
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