This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients. It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.
The study includes screening and baseline, randomization \& intervention, in-hospital visit, at 30±3 days visit after fibrinolytic therapy. Following an initial eligibility screening assessment, all eligible patients who have signed the informed consent will be randomly assigned by an interactive Web-based central system for fibrinolytic therapy with either rhTNK-tPA or rt-PA. The standard care should be given to all patients except for the study interventions. Prior to fibrinolytic administration, enoxaparin (30-mg intravenous) or Un- Fractionated Heparin (maximum 4000U, intravenous) should be administered, combined with antiplatelet therapy consisted of both clopidogrel and aspirin in a 300-mg loading dose followed by routine dosage. Successful reperfusion according to the clinical evidence (EKG) should be assessed after fibrinolytic therapy.TIMI flow should be assessed for those patients with 24 hours coronary angiography. MACCE and bleeding events should be followed up and documented during the study until 30 days after fibrinolytic therap. An independent adjudication committee will judge the major endpoint events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
818
Dose:16mg; Mode of admin: Single bolus Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.
Dose:50mg; Mode of admin: administered as an 8-mg initial IV bolus followed by an infusion of 42 mg over the next 90 minutes Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.
Guangzhou Recomgen Biotech Co., Ltd.
Guangzhou, Guangdong, China
The proportion of patients with TIMI grade 2 or 3 flow in the infarct-related artery after therapy (Limited to the subgroup for coronary angiography within 24 hours after therapy)
A patent IRA was defined as TIMI grade 2 or 3 flow on the angiogram
Time frame: within 24 hours after therapy
The rate of MACCE (Major Adverse Cardiovascular and Cerebrovascular Events)
MACCE composited of total death, non-fatal recurrent MI, non-fatal stroke (ischemic and Hemorrhage), PCI for failed reperfusion and PCI for reocclusion
Time frame: within 30 days after the start of fibrinolytic therapy
The rate of successful reperfusion with clinical evidences
Time frame: within 24 hours of fibrinolytic therapy
The in-hospital MACCE
Time frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital and 30-day all-cause mortality
Time frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month) and 30 days after the start of study interventions
The in-hospital and 30-day cardiac deaths
Time frame: during hospitalization (from the date of admission to the date of discharge) and 30 days after the start of study interventions, assessed up to 1 month
The in-hospital recurrent MI
Time frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The 30-day revascularization
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Time frame: 30 days after the start of therapy
The in-hospital intracranial hemorrhage (ICH)
Time frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital major GI bleeding events
Time frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital total bleeding events
Time frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)