Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT02835534
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02835534
Study Brief:
Protocol Section:
NCT02835534