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โ† Trials
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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

RecruitingPhase 3Ages 18 Years - anyAllBeijing Tiantan Hospital
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In plain words

What the trial is, and whether it could suit you

The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 1)Age โ‰ฅ 18 years old; * 2)Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time'; * 3)Pre-stroke modified Rankin scale (mRS) score โ‰ค1; * 4)Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive) or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function); * 5)Neuroimaging: 1. Middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA, being responsible for signs and symptoms of acute ischemic stroke; 2. target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio \>1.2, and mismatch volume \>10mL); * 6)Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: * 1)Present as a significant low-density lesion on CT * 2)Allergy to tenecteplase * 3)Rapidly improving symptoms at the discretion of the investigator * 4)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 * 5)Persistent blood pressure elevation (systolic โ‰ฅ185 mmHg or diastolic โ‰ฅ110 mmHg), despite blood pressure-lowering treatment * 6)Blood glucose \<2.8 or \>22.2 mmol/L (point of care glucose testing is acceptable) * 7)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 * 8)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 aPTT greater than the upper limit of normal * 9)Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included) * 10)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 * 11)Any terminal illness such that the patient would not be expected to survive more than 1 year * 12)Unable to perform CTP or PWI * 13)Hypodensity in \>1/3 MCA territory on non-contrast CT for MCA occlusion, and pc-ASPECTS \<6 for BAO * 14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI * 15)Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion) * 16)Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial * 17)Unlikely to adhere to the trial protocol or follow-up * 18)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 * 19)Participation in other interventional clinical trials within the previous 3 months
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What it tests

  • Tenecteplase (0.25mg/kg)
  • Standard medical treatment
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Where

1 site
Beijing tiantan hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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