Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay

The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay

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.

Eligibility Criteria:
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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. 2. 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.