Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III

Korábbi kezelés

• Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days;
• Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation or giant aneurysm;
• Participation in other interventional clinical trials within the previous 3 months.

Más betegség

• Allergy to tenecteplase;
• NIHSS consciousness score 1a >2, or epileptic seizure, hemiplegia after seizures ( Todd's palsy ) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate;
• Any terminal illness such that the patient would not be expected to survive more than 1 year;
• Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI;
• Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;

Laborértékek

• Blood glucose <2.8 or >22.2 mmol/L (point of care glucose testing is acceptable );
• Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR >1.7 or prothrombin time >15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an elevated aPTT greater than the upper limit of normal;
• Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included);

Egyéb

• Intended to proceed to endovascular treatment;
• Rapidly improving symptoms at the discretion of the investigator;
• Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg), despite blood pressure-lowering treatment;
• Unable to perform CTP or PWI;
• Hypodensity in >1/3 MCA territory on non-contrast CT;
• Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);
• Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial;
• Unlikely to adhere to the trial protocol or follow-up;

• Age ≥18 years old;
• Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrolment; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
• Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA, internal carotid artery, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;
• Pre-stroke modified Rankin scale (mRS) score≤1;
• Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);
• Neuroimaging: target mismatch profile on CTP or MRI+MR Perfusion (ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;
• Written informed consent from patients or their legally authorized representatives.