NCT02182011已完成3 期
An Open-label, Randomised, Parallel-group Comparison to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With AMI
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
研究概览
简要总结
Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values.
Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence of adverse events (AE's), in -hospital complications, major or minor bleedings and serious adverse events.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of symptoms of AMI within 6 hours from randomisation
- •A twelve-lead electrocardiogram (ECG) showing ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new left bundle-branch block
排除标准
- •Hypertension defined as blood pressure > 180/110 mmHg (systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg) on repeated measurements during current admission prior to randomisation
- •Use of abciximab (ReoPro®) within the preceding 7 days or eptifibatide (Integrilin®) or tirofiban (aggrastat®) within the past 48 hours
- •Use of heparin within the preceding 12 hours
- •Current therapeutic oral anticoagulation
- •Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
- •Any minor head trauma and any other trauma occurring after the onset of the current myocardial infarction
- •Any known history of stroke or transient ischemic attack or dementia
- •Any known structural damage of the central nervous system
- •Ruptured aortic aneurism
- •Active bleeding
- •Prolonged cardiopulmonary resuscitation (> 10 minutes) in the previous two weeks
- •Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test
- •Any known active participation in another investigative drug study or device protocol in the past 30 days
- •Previous enrolment in this study
- •Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy were initiated
- •Inability to follow the protocol and comply with follow-up requirements
研究组 & 干预措施
Tenecteplase
Experimental
Single i.v. bolus followed by infusion, weight adjusted
干预措施: Tenecteplase (Drug)
Alteplase
Active Comparator
Single i.v. bolus followed by infusion
干预措施: Alteplase (Drug)
Streptokinase
Active Comparator
I.V. infusion
干预措施: Streptokinase (Drug)
结局指标
主要结局
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
时间窗: Baseline, 2 hours after start of treatment
次要结局
- Changes from baseline in TAT(Baseline, 6 and 24 hours after start of treatment)
- Changes from baseline in D-dimers(Baseline, 2, 6 and 24 hours after start of treatment)
- Changes from baseline in prothrombin fragments 1+2 (F1+F2)(Baseline, 2, 6 and 24 hours after start of treatment)
- Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)(Baseline, 2, 6 and 24 hours after start of treatment)
- Changes from baseline in plasmin-antiplasmin complex (PAP)(Baseline, 2, 6 and 24 hours after start of treatment)
- Occurrence of adverse events (AE's)(Up to 30 days)
- Occurrence of major bleedings(Up to 30 days)
- Occurrence of minor bleedings(Up to 30 days)
- Occurrence of serious adverse events (SAE's)(Up to 30 days)
- Occurrence of in-hospital complications(Start of treatment until discharge from hospital)
研究者
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