NCT02191670已完成不适用
A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Number of serious adverse events (SAE)
研究概览
简要总结
Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation. Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction in usual routine treatment after market launch
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •on a twelve-lead electrocardiogram (ECG), 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 left bundle-branch block
排除标准
- •significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis
- •patients with current concomitant oral anticoagulant therapy with International Normalised Ratio (INR) > 1.3
- •any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
- •severe uncontrolled arterial hypertension (hypertension defined as blood pressure 180/110 mm Hg (systolic BP > 180 mm Hg and/or diastolic BP > 100 mm Hg) on one single reliable measurement during current admission prior to study enrolment
- •major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI), recent trauma to the head or cranium
- •prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
- •severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis
- •diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions
- •active peptic ulceration
- •arterial aneurysm and known arterial/venous malformation
- •neoplasm with increased bleeding risk
- •Acute pericarditis and/or subacute bacterial endocarditis
- •Acute pancreatitis
- •hypersensitivity to the active substance tenecteplase and to any of the excipients
- •use of Abciximab (ReoPro®) or other marketed GPIIb/IIIa antagonists within the preceding 12 hours
- •any minor head trauma and any other trauma occurring after onset of the current myocardial infarction
- •any known history of stroke or transient ischemic attack or dementia
- •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 enrollment in this study
- •inability to follow protocol and comply with follow-up requirements
- •any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
研究组 & 干预措施
METALYSE®
干预措施: METALYSE® (Drug)
结局指标
主要结局
Number of serious adverse events (SAE)
时间窗: up to 30 days
次要结局
- In-hospital rate of non-fatal cardiac events(up to 30 days)
- In-hospital rate of major bleeding(up to 30 days)
- In-hospital rate of death(up to 30 days)
- In-hospital rate of stroke(up to 30 days)
- In-hospital rate of intracranial hemorrhage(up to 30 days)
- Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke(up to 30 days)
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