EARLY Routine Catheterization After Alteplase Fibrinolysis vs. PPCI in ST-Segment-Elevation MYOcardial Infarction (EARLY-MYO)

This is an interventional treatment trial for Acute ST-segment Elevation Myocardial Infarction focused on measuring Myocardial Infarction, Catheterization, Fibrinolysis Read More

Inclusion Criteria:

• Age: over 18 or 18 years old, less than 75 years old;
• Patents with myocardial infarction who have symptom onset within 6h before randomization;
• ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
• Patents with an expected PCI-related delay [expected time delay from FMC to first balloon dilation≥90 min, and difference between the time of FMC to balloon dilation minus the time from FMC to start of fibrinolysis ≥60 minutes)];
• Signed informed consent form prior to trial participation.

Exclusion Criteria:

1. Evidence of cardiac rupture;
2. ECG: new left bundle branch block;
3. "Diagnosis to balloon inflation" time over 3 hours;

4. Thrombolysis contradictions:

   • Definite cerebral apoplexy history;
   • 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);
   • 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, 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;

5. Severe complication

   • Other diseases with life expectancy ≤12 months;
   • Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known acute pancreatitis;
   • Known acute pericarditis and/or subacute bacterial endocarditis;
   • Arterial aneurysm, arterial/venous malformation and aorta dissection;

6. Complex heart condition

   • Cardiogenic shock(SBP <90 mmHg after fluid infusion or SBP<100 mmHg after vasoactive drugs);
   • PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG);
   • Previously known multivessel coronary artery disease not suitable for revascularization;
   • Hospitalisation for cardiac reason within past 48 hours;

7. Not suitable for clinical trial

   • Inclusion in another clinical trial;
   • Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
   • Pregnancy or lactating;
   • Body weight <40kg or >125kg;
   • Known hypersensitivity to any drug that may appear in the study;
   • 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.