TRIANA: A Randomized Trial to Compare the Efficay and Safety of Thrombolysis With Primary Angioplasty as Initial Reperfusion Therapy in Older Patients (>= 75 Years Old) With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 266
- 试验地点
- 23
- 主要终点
- Incidence of Death or Reinfarction or Disabling Stroke
研究概览
简要总结
General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients >=75 years old with ST-segment elevation or LBBB AMI <6 hours of evolution without contraindications for TT.
Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT in patients >=75 years old with AMI.
Participating Centers: 27 Spanish hospitals performing >50 PA/year. Primary Endpoint (PE): Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30 days. There are also 7 secondary endpoints (SE).
Procedure: Diagnosis of inclusion/exclusion criteria --> Centralized randomization --> Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months. Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety Committee and Event Adjudication Committee formed by experts not participating in the study.
详细描述
Hypothesis of the study. In patients of 75 or more years of age with AMI and ST-elevation or LBBB, the treatment strategy based on primary angioplasty is superior to the treatment strategy based on initial fibrinolytic therapy for reducing the incidence of death, re-infarction and disabling CVA at 30 days. This benefit is maintained at 12 months.
Objectives General objective of the study. To compare the efficacy and safety of primary angioplasty and fibrinolytic treatment in >=75 year-old patients with AMI eligible for fibrinolytic therapy in Spanish medical centers with an active program of primary angioplasty.
Primary end point: Incidence of the combined end point of all-cause death, re-infartion or disabling stroke at 30 days
Secondary end points:
- All-cause death at 30 days
- Incidence of the combined end point of all-cause death, disabling CVA or de novo heart failure at 30 days
- Incidence of recurrent ischemia requiring emergency catheterization in the first 30 days
- Cause of death at 30 days classified in three groups:
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Thrombolysis
Weight adjusted tenecteplase bolus + Unfrationated heparin
干预措施: Tenecteplase + UFH (+ clopidogrel, since 01/97) (Drug)
Primary angioplasty
Primary angioplasty
干预措施: Primary angioplasty (Procedure)
结局指标
主要结局
Incidence of Death or Reinfarction or Disabling Stroke
时间窗: 30 days
Incidence of all-cause death or myocardial reinfarction or disabling stroke
Death/Reinfarction/Disabling Stroke at 30 Days
时间窗: 30 days
Incidence of Death or Reinfarction or Disabling Stroke at 30 days
次要结局
未报告次要终点
研究者
Héctor Bueno
(Past) President. WG on IHD
Spanish Society of Cardiology