NCT04516993

Completed

Phase 2

Prospective, Multicenter, Open, End-point Blinded, Stratified Block Randomized, Parallel Positive Controlled Clinical Trial of Tenecteplase in Acute Ischemic Stroke With Large Vessel Occlusion Over Time Window

Huashan Hospital1 site in 1 country224 target enrollmentSeptember 28, 2021

ConditionsStroke

InterventionsTenecteplase The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)

DrugsTenecteplase The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)

Overview

Phase: Phase 2
Intervention: Tenecteplase
Conditions: Stroke
Sponsor: Huashan Hospital
Enrollment: 224
Locations: 1
Primary Endpoint: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To explore the efficacy and safety of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes

Registry

clinicaltrials.gov

Start Date

September 28, 2021

End Date

September 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huashan Hospital

Responsible Party

Principal Investigator

Qiang Dong

Director of Neurology Department

Huashan Hospital

Eligibility Criteria

Inclusion Criteria

•Patients presenting with anterior circulation acute ischaemic stroke
•Time from onset to treatment 4.5h-24h
•Patient's age is \>= 18 years，\<= 80
•Pre-stroke mRS score of \<= 2
•Clinically significant acute neurologic deficit
•Baseline National Institute of Health stroke scale \>= 6
•Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
•Multimodal CT/magnetic resonance imaging: perfusion lesion volume (DT \> 3 s) to infarct core volume ratio (rCBF\<30% or diffusion-weighted imaging lesion) \>1.2, absolute difference \>10 ml, and ischemic core volume \<70ml
•Informed consent was obtained from patients.

Exclusion Criteria

•Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
•Rapidly improving symptoms (patient with an NIHSS score decrease to \< 4 at randomization)
•Pre-stroke mRS score of \> 2
•Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
•Infarct core \>1/3 middle cerebral artery (MCA) territory
•Platelet count \< 100x10\^9/L
•Symptoms were caused by low blood glucose \< 2.7 mmol/l
•Severe uncontrolled hypertension, i.e. systolic blood pressure \>= 180 mmHg or diastolic blood pressure \>=100 mmHg
•Current use of warfarin with a prolonged prothrombin time (INR \> 1.7 or prothrombin time \> 15s)
•Use of low molecular weight heparin within 24 hours

Arms & Interventions

Tenecteplase arm

Intervention: Tenecteplase

Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)

The best treatment selected by local doctors

Intervention: The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)

Outcomes

Primary Outcomes

patients without endovascular therapy obtained >50% reperfusion at 4-6 hours

Time Frame: 4-6 hours

Without endovascular therapy: \>50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours

patients with endovascular therapy: mTICI score 2b or better at initial angiogram

Time Frame: Before endovascular therapy

With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy

no symptomatic intracranial hemorrhage at 24-36 hours

Time Frame: 24-36 hours

No symptomatic intracranial hemorrhage at 24-36 hours

Secondary Outcomes

Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours(24-36 hours)
Clinical safety outcome: Rate of systemic bleeding(90 days (plus or minus 7 days))
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours(24-36 hours)
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours(24-36 hours)
Clinical safety outcome: death within 90 days(90 days (plus or minus 7 days))
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography(4-6 hours)
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion(3-5 days)
Clinical efficacy outcome: percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)(90 days (plus or minus 7 days))
Clinical efficacy outcome: incident event(90 days (plus or minus 7 days))
Clinical efficacy outcome: NIHSS change(24 hours (plus or minus 2 hours))
Clinical efficacy outcome: percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days)(90 days (plus or minus 7 days))
Barthel index(90 days (plus or minus 7 days))
Imaging efficacy outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours(4-6 hours)
Imaging efficacy outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram(Before endovascular therapy)
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days(3-5 days)
Clinical efficacy outcome: NIHSS change at 7 days(7 days (plus or minus 2 days))
Clinical efficacy outcome: vascular death within 90 days(90 days (plus or minus 7 days))
Clinical efficacy outcome: major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)(24-36 hours)