The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Guangzhou Recomgen Biotech Co., Ltd.
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital; Peking University
• Treatments: Anticoagulants; Aspirin; Calcium heparin; Clopidogrel; Heparin; Plasminogen; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. 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

2. Onset of continuous ischemic symptoms of STEMI ≤6 hours prior to randomisation

3. Anticipated Delay to Performing Primary PCI >60mins，or time from hospital arrival to to balloon inflation >90mins

4. Signed Informed consent received prior to participation the study

Exclusion Criteria:

1. Non-ST-segment-elevation myocardial infarction or unstable angina

2. Reinfacrtion

3. Cardiacgenic shock

4. Suspected aortic dissection

5. New left bundle branch block in ECG

6. 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

7. 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

8. Administration of fibrinlytic therapy prior to participation

9. Weight below 50 kg

10. Known current histroy of fall-down accident

11. 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