NCT04752345Unknown不适用
A Prospective Randomized Multi-center Clinical Trial Comparing Different Fibrinolysis-transfer Percutaneous Coronary Intervention Strategies in Acute ST-segment Elevation Myocardial Infarction
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 632
- 主要终点
- The rate of major composite endpoint events
研究概览
简要总结
The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay
详细描述
OPTIMAL-REPERFUSION is an investigator-initiated, prospective, multicenter, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of medical contact to percutaneous coronary intervention ≥120 min will be randomized to a reduced-dose facilitated PCI strategy (reduced-dose fibrinolysis combined with simultaneous transfer for immediate invasive therapy with a time interval between fibrinolysis to PCI < 3 hours) or to pharmacoinvasive treatment. The primary endpoint is the composite of death, reinfarction, refractory ischemia, congestive heart failure, or cardiogenic shock at 30-days.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or over and less than 75 years old;
- •Patents with STEMI with symptom onset persisted more than 30mim and within 6 h before randomization;
- •ECG >=2 mm ST-segment elevation in 2 contiguous precordial leads or >=1 mm ST- segment elevation in 2 contiguous extremity leads, or new left bundle branch block;
- •Patents with an expected time from FMC to PCI >=120 min.
- •Signed informed consent form prior to trial participation.
排除标准
- •Fibrinolysis contradictions: Definite hemorrhagic stroke history;ischemic stroke or cerebrovascular accident in nearly 6 months;
- •Any 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);
- •Active bleeding or known bleeding disorder/diathesis; 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 (warfarin or coumadin);
- •Arterial aneurysm, arterial/venous malformation and aorta dissection; Uncontrolled hypertension, defined as a single blood pressure measurement >=180/110 mm Hg (systolic BP >=180 mm Hg and/or diastolic BP >=110 mm Hg) prior to randomisation;
- •Major surgery, biopsy of a parenchymal organ, noncompressible vascular puncture, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction);
- •prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks; major surgery pending in the following 30 days.
- •Complex heart condition Evidence of cardiac rupture; Pre-existing heart failure and previous New York heart function classification III-IVCardiogenic shock (SBP <90mmHg after fluid infusion or SBP<100mmHg after vasoactive drugs);
- •PCI within previous 1 month or previous bypass surgery;
- •Myocardial infarction in the past year or previously known coronary artery disease not suitable for revascularization;
- •Known acute pericarditis and/or subacute bacterial endocarditis;
- •Hospitalization for cardiac reason within past 48 hours;
- •Severe comorbidity: Other diseases with life expectancy <=12 months;
- •Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis);
- •neutropenia, thrombocytopenia;
- •Severe COPD with hypoxemia;
- •Not suitable for clinical trial: Inclusion in another clinical trial; Previous enrollment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
- •Pregnant or lactating;
- •Body weight <40kg;
- •Known hypersensitivity to any drug that may be used in the study;
- •Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk.
结局指标
主要结局
The rate of major composite endpoint events
时间窗: 30 days
Composite of death, reinfarction, refractory ischaemia, congestive heart failure, or cardiogenic shock
次要结局
- Peak CK-MB level(48 hours after system onset)
- The rate of reinfarction(1 year)
- The rate of congestive heart failure(1 year)
- The rate of major ventricular arrhythmia(1 year)
- The rate of ischemia stroke(1 year)
- The rate of stent thrombosis(1 year)
- Number of Participants with TIMI flow grade (TFG) 3 for epicardial reperfusion(1 minute after stent was deployed)
- The rate of death(1 year)
- The rate of target vessel revascularization(1year)
- The rate of Cardiogenic shock(1 year)
- Adverse events(1 year)
- Number of Participants with TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion(1 minute after stent was deployed)
- Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization(60min after the stent was deployed)
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