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

• Status: Completed
• Trial end date: 2016-09-12
• Target enrollment: 0
• Participant gender: All

Summary

The EARLY-MYO (EARLY routine catheterization after alteplase fibrinolysis vs. primary PCI in acute ST-segment elevation MYOcardial infarction) is an investigator-initiated, prospective, multicenter, randomized (1:1), open-label, actively-controlled, parallel group, non-inferiority trial comparing the efficacy and safety of a PhI strategy with half-dose fibrinolysis versus PPCI in STEMI patients presenting within 6 hours after symptom onset and with an expected PCI-related delay of ≥60 min.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Tissue Plasminogen Activator

Criteria

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.