A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-hospital Cardiac Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,050
- 试验地点
- 68
- 主要终点
- The primary endpoint of this study is the 30-day survival rate
研究概览
简要总结
The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.
详细描述
The trial is a prospective, international, multi-centre, randomised (1:1), double-blind, parallel group comparison conducted for investigating the efficacy and safety of tenecteplase and placebo in patients with cardiac arrest of presumed cardiac origin.
Approximately 1300 patients (two groups of 650 patients; tenecteplase or matching placebo) suffering from witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, who are treated with ALS-CPR will be randomised at approximately 40 study centres. Randomisation is done immediately after insertion of an IV line is established. Study drug application, as a single IV bolus over 5-10 seconds, should be done immediately after the first vasopressor application during the ALS-CPR procedure.
PCI facilities will be required at all participating sites, i.e. hospitals receiving patients.
Study Hypothesis:
The primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of 30-day survival (30daysurv).
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
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
- •Age at least 18 years (known or estimated; no upper limit)
- •Out-of-hospital cardiac arrest of presumed cardiac origin (including recurrent cardiac arrest(s) after initial ROSC)
- •Witnessed (by eye and/or ear) cardiac arrest
- •BLS-CPR started within 10 min of onset (known or estimated time) and may be performed for up to 10 min, followed by ALS-CPR - or ALS-CPR started within 10 min of onset (known or estimated time)
- •Subjects who meet any of the following criteria will be excluded from randomisation into the study:
- •In-hospital cardiac arrest
- •Cardiac arrest of presumed non-cardiac origin (e.g., drug overdose, carbon monoxide poisoning, drowning, hypothermia, exsanguination, electrocution, asphyxia, hypoxia, trauma, cerebrovascular accident)
- •Obvious significant internal bleeding
- •Known neurological impairment
- •Known coagulation disorder
- •Known pregnancy
- •Known current participation in any other clinical study
- •Known hypersensitivity to study medication
- •Institutionalised subjects (e.g., prisoner)
- •Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
排除标准
- 未提供
结局指标
主要结局
The primary endpoint of this study is the 30-day survival rate
时间窗: 30 days
The co-primary endpoint of this study is hospital admission
时间窗: 30 days
次要结局
- Return of spontaneous circulation (ROSC)(30 days)
- 24-hr survival(24 hours)
- Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first(30 days)
- Major bleeds up to hospital discharge or day 30, whichever came first(30 days)
- Neurological and overall outcome at hospital discharge or at day 30, whichever came first(30 days)