NCT04086147

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

April 15, 2019

Last Update Submit

March 30, 2022

Conditions

Stroke

Keywords

acute ischemic strokelarge vessel occlusionthrombolysistenecteplasedosagecomputed tomographymagnetic resonance imagingdiffusion weighted imagingearly combined imaging outcomesmodified Rankin scaletime window beyond 4.5 hours

Outcome Measures

Primary Outcomes (3)

  • Favourable outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours

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

    4-6 hours

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

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

    Before endovascular therapy

  • Favourable outcome: no symptomatic intracranial hemorrhage at 24-36 hours

    No symptomatic intracranial hemorrhage at 24-36 hours

    24-36 hours

Secondary Outcomes (13)

  • 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

    3-5 days

  • Clinical efficacy outcome: major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)

    24-36 hours

  • Clinical efficacy outcome: NIHSS change

    24-36 hours

  • Clinical efficacy outcome: excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days

    90 days

  • +8 more secondary outcomes

Study Arms (2)

Low dose tenecteplase

EXPERIMENTAL
Drug: Low dose tenecteplase

High dose tenecteplase

EXPERIMENTAL
Drug: High dose tenecteplase

Interventions

Low dose tenecteplaseDRUG

Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)

Low dose tenecteplase
High dose tenecteplaseDRUG

Intravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg)

High dose tenecteplase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with anterior circulation acute ischaemic stroke
  • Time from onset to treatment 4.5h-24h
  • Patient's age is ≥18 years
  • Pre-stroke mRS score of \<= 2
  • Clinically significant acute neurologic deficit
  • 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.

You may not qualify if:

  • 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
  • Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
  • Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
  • Arterial puncture at noncompressible site in previous 7 days
  • Major surgery in previous 14 days which poses risk in the opinion of the investigator
  • Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (3)

  • Liu X, Hong L, Zhao G, He Z, Wang X, Zhu J, Li S, Zhang A, Cao N, Ling Y, Chen X, Guo Y, Fang Q, Wang Z, Dong Q, Cheng X. Regional perfusion parameters as potential indicators of parenchymal hematoma risk following reperfusion therapy for acute ischemic stroke in the extended time window. Ther Adv Neurol Disord. 2025 Dec 21;18:17562864251406032. doi: 10.1177/17562864251406032. eCollection 2025.

    PMID: 41446320DERIVED

  • Hong L, Zhu J, He Z, Wang X, Li S, Liu X, Ling Y, Yang L, Fang Q, Dong Q, Cheng X; CHABLIS-T Investigators. Effect of Time Delay on Reperfusion After Tenecteplase in an Extended Time Window: Analysis From the CHABLIS-T Trials. J Am Heart Assoc. 2025 Jun 17;14(12):e040994. doi: 10.1161/JAHA.124.040994. Epub 2025 Jun 11.

    PMID: 40497495DERIVED

  • Cheng X, Hong L, Churilov L, Lin L, Ling Y, Zhang J, Yang J, Geng Y, Wu D, Liu X, Zhou X, Zhao Y, Zhai Q, Zhao L, Chen Y, Guo Y, Yu X, Gong F, Sui Y, Li G, Yang L, Gu HQ, Wang Y, Parsons M, Dong Q; CHABLIS-T collaborators. Tenecteplase thrombolysis for stroke up to 24 hours after onset with perfusion imaging selection: the umbrella phase IIa CHABLIS-T randomised clinical trial. Stroke Vasc Neurol. 2024 Nov 5;9(5):551-559. doi: 10.1136/svn-2023-002820.

    PMID: 38286484DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen ActivatorSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neurology Department

Study Record Dates

First Submitted

April 15, 2019

First Posted

September 11, 2019

Study Start

December 9, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

CN(1)