Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III (TRACEIII)

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    516
  • sponsor
    Beijing Tiantan Hospital
Updated on 26 March 2022

Summary

The trial is a multicenter, prospective, block randomized, open label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to large vessel occlusion within 4.5-24 hours of symptom onset (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.

Description

The study will be a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE), controlled phase 3 trial (2 arms with 1:1 randomization) in ischemic stroke due to large vessel occlusion with perfusion mismatch up to 24 hours of symptom onset. The target mismatch profiles on CTP or MRI perfusion weighted imaging include ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL demonstrated by a certified automatic software. The sample size is 516 patients.

Details
Condition Ischemic Stroke, Acute
Treatment Standard Medical Treatment, rhTNK-tPA ( 0.25 mg/kg, Max 25 mg )
Clinical Study IdentifierNCT05141305
SponsorBeijing Tiantan Hospital
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 years
Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last normal time'
Pre-stroke mRS score≤1
Baseline NIHSS 6-25 ( both included )
Neuroimaging: Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA ( carotid artery occlusion refers to carotid artery or intracranial artery, with or without tandem occlusion ), and target mismatch profile on CT perfusion ( CTP ) or MRI_perfusion weighted imaging ( MRI_PWI ) including ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL demonstrated by a certified automatic software
written informed consent from patients or their legally authorized representatives

Exclusion Criteria

Intended to proceed to endovascular treatment
Allergy to rhTNK-tPA
Rapidly improving symptoms at the discretion of the investigator
NIHSS consciousness score 1a >2, or epileptic seizure, hemiplegia after seizures ( Todd's palsy ) or combined with other nervous/mental illness not able to cooperate or unwilling to cooperate
Persistent blood pressure elevation ( systolic ≥180 mmHg or diastolic ≥100 mmHg ), despite blood pressure lowering treatment
Blood glucose <2.8 or >22.2 mmol/L ( on random glucose testing is acceptable )
Active internal bleeding or at high risk of bleeding, e.g.: Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR >1.7 or prothrombin time >15 seconds; if 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; if on 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 ( but patients on antiplatelet agents can be included )
Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial haemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation or giant aneurysm
Any terminal illness such that patient would not be expected to survive more than 1 year
Unable to perform CTP or PWI
Hypodensity in >1/3 MCA territory on non-contrast CT
Acute or past intracerebral hemorrhage ( ICH ) identified by CT or MRI
Multiple arterial occlusion ( bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion )
Pregnant women, nursing mothers, or reluctant to agree taking effective contraceptive measures during the period of trial subjects
Unlikely to adhere to the trial protocol or follow-up
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
Participation in other interventional clinical trials within the previous 3 months
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