NCT02181985已完成3 期
A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction: ASSENT 3 (Assessment of the Safety and Efficacy of New Thrombolytic Regimens)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,989
- 主要终点
- Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)
研究概览
简要总结
The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C).
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 six hours prior to randomisation
- •A twelve-lead electrocardiogram with one of the following: 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
- •Informed consent received
排除标准
- •Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on repeated measurements during current admission prior to randomization
- •Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days
- •Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
- •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
- •Any known structural damage of the central nervous system
- •Prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks
- •Current oral anticoagulation
- •Standard unfractionated heparin (heparin sodium) >5000 IU or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin
- •Known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10**9/l))
- •Known renal insufficiency (prior S-creatinine >2.5 mg% (>220 μmol/l) for men and >2.0 mg% (>175 μmol/l)) for women
- •Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control
- •Treatment with an investigational drug under another study protocol in the past 7 days
- •Previous enrollment in this study
- •Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin
- •Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
- •Inability to follow protocol and comply with follow-up requirements
研究组 & 干预措施
TNK-tPA + heparin
Active Comparator
干预措施: Full dose TNK-tPA (Drug)
TNK-tPA + heparin
Active Comparator
干预措施: Heparin (Drug)
TNK-tPA + enoxaparin
Experimental
干预措施: Full dose TNK-tPA (Drug)
TNK-tPA + enoxaparin
Experimental
干预措施: Enoxaparin (Drug)
TNK-tPA + abciximab + heparin
Experimental
干预措施: Half dose TNK-tPA (Drug)
TNK-tPA + abciximab + heparin
Experimental
干预措施: Heparin (Drug)
TNK-tPA + abciximab + heparin
Experimental
干预措施: Abciximab (Drug)
结局指标
主要结局
Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)
时间窗: Up to 30 days after discharge from hospital
Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia
时间窗: Up to 30 days after discharge from hospital
次要结局
未报告次要终点
研究者
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