Trial | NCT02835534  Report issue

Title

The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI
The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute ST Elevation Myocardial Infarction(STEMI): a Multi-center, Randomized, Open, Parallel, Non-inferiority, Active Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    818
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 Started
May 31
2016
Primary Completion
Oct 31
2019
Study Completion
Jan 31
2020
Last Update
May 25
2022

Drug rhTNK-tPA

Dose:16mg; Mode of admin: Single bolus Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.

  • Other names: Recombinant Human TNK Tissue-type Plasminogen Activator

Drug alteplase

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.

  • Other names: rt-PA

rhTNK-tPA Experimental

rhTNK-tPA; Dose:16mg; Mode of admin: Single bolus Dose:50mg; Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.

rt-PA Active Comparator

Drug:alteplase;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.

Criteria 

Inclusion Criteria:

Diagnosis of acute STEMI（meet with both conditions）:

Ischemic chest pain ≥30mins in duration
ST elevation ≥0.1 mV in two or more limb ECG leads or ≥0.2 mV in two or more contiguous precordial leads
Onset of continuous ischemic symptoms of STEMI ≤6 hours prior to randomisation
Anticipated Delay to Performing Primary PCI >60mins，or time from hospital arrival to to balloon inflation >90mins
Signed Informed consent received prior to participation the study

Exclusion Criteria:

Non-ST-segment-elevation myocardial infarction or unstable angina
Reinfacrtion
Cardiacgenic shock
Suspected aortic dissection
New left bundle branch block in ECG

Absolute and relative contraindications for Fibrinolytic Therapy in STEMI(referred from 2015 China STEMI Management Guideline）：

Severe uncontrolled hypertension (unresponsive to emergency Therapy,BPs > 180 mmHg and/or BPd > 110 mmHg)
Any prior ICH,stroke with unknown cause, Ischemic stroke within 3 months
Known structural cerebral vascular lesion, malignant intracranial neoplasm
Active bleeding, or bleeding diathesis, active peptic ulcer
Significant closed-head or facial trauma within 3 months
Intracranial or intraspinal surgery within 2 months
Recent internal bleeding within 4 weeks
Major surgery within 3 weeks, or Traumatic
Prolonged cardiopulmonary resuscitation (>10 minutes)
Noncompressible vascular punctures within 2 weeks
Current use of anticoagulant therapy

Current or with a history of significant diseases：

Damage to the central nervous system
Severe renal or hepatic dysfunction, blood system diseases,
Present with cardiac rupture evidence
Acute pericarditis,Subacute bacterial endocarditis, Septic thrombophlebitis or occluded AV cannula at seriously infected site
Malignancy
High likelihood of left heart thrombus, e.g., mitral stenosis with atrial fibrillation
Diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions
History of PCI or coronary artery bypass graft（CABG）within 1 month
Administration of fibrinlytic therapy prior to participation
Weight below 50 kg
Known current histroy of fall-down accident

Any other unfavourable conditions for participation：

Known participation in other clinical trials
Known to allergic to rhTNK-tPA or tPA or relevant vehicle
Pregnancy or lactation
Mental disorder
Present with any unsuitable conditions for participation or completion of the study at the discretion of their treating physician
No Results Posted