STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 609
- 试验地点
- 50
- 主要终点
- Successful Reperfusion
研究概览
简要总结
In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal or greater than 60 years
- •Onset of symptoms < 3 hours prior to randomisation
- •12-lead ECG indicative of an acute STEMI (ST-elevation will be measured from the J point; scale: 1 mm per 0.1 mV):
- •≥ 2 mm ST-elevation across 2 contiguous precordial leads (V1-V6) or leads I and aVL for a minimum combined total of ≥ 4 mm ST-elevation or
- •≥ 2 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of ≥ 4 mm ST-elevation
- •Informed consent received
排除标准
- •Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours
- •Previous CABG
- •Left bundle branch block or ventricular pacing
- •Patients with cardiogenic shock - Killip Class 4
- •Patients with a body weight < 55 kg (known or estimated)
- •Uncontrolled hypertension, defined as sustained blood pressure ≥ 180/110 mm Hg (systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg) prior to randomisation
- •Known prior stroke or TIA
- •Recent administration of any i.v. or s.c. anticoagulation within 12 hours, including unfractionated heparin, enoxaparin, and/or bivalirudin or current use of oral anticoagulation (i.e. warfarin or a NOACs)
- •Active bleeding or known bleeding disorder/diathesis
- •Known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months)
- •Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction)
- •Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk
- •Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
- •Known acute pericarditis and/or subacute bacterial endocarditis
- •Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- •Known severe renal insufficiency
- •Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
- •Known allergic reactions to tenecteplase, clopidogrel, enoxaparin and aspirin
- •Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
研究组 & 干预措施
Pharmaco-invasive strategy
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
干预措施: Tenecteplase (Drug)
Pharmaco-invasive strategy
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
干预措施: Clopidogrel (Drug)
Pharmaco-invasive strategy
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
干预措施: Coronary angiography (Procedure)
Standard primary PCI
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
干预措施: Primary PCI (Procedure)
结局指标
主要结局
Successful Reperfusion
时间窗: 30 min post angiogram/PCI
Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days
时间窗: 30 days
Total Stroke
时间窗: 30 days
Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)
Major Non-intrancranial Bleedings
时间窗: 30 days
次要结局
未报告次要终点