StrokePhase 2CHABLIS-TNCT04086147
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase
A Phase 2 study testing Low dose tenecteplase and High dose tenecteplase in people with Stroke, run by Huashan Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Low dose tenecteplase and High dose tenecteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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)
- Significant head trauma or prior stroke in previous 3 months
- History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
- Hereditary or acquired haemorrhagic diathesis
- Active internal bleeding
- Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
- Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
- Pregnancy
- Various dying diseases with life expectancy ≤3 months
- Other conditions in which doctors believe that participating in this study may be harmful to the patient
- Patients participated in any observational trial in 30 days
- Allergic to the test drug and its ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chinese Acute Tissue-based Imaging Selection for Lysis in Stroke: a Prospective, Multicentre, Randomized, Open-label, Rater-blinded, Randomized Trial
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
- Conditions
- Stroke
- Being tested
- Low dose tenecteplase, High dose tenecteplase
- Keywords
- acute ischemic stroke, large vessel occlusion, thrombolysis, tenecteplase, dosage, computed tomography, magnetic resonance imaging, diffusion weighted imaging, early combined imaging outcomes, modified Rankin scale, time window beyond 4.5 hours
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose tenecteplaseDrug
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
High dose tenecteplaseDrug
Intravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg)
| Study group | Role | What they receive |
|---|---|---|
| Low dose tenecteplase | Experimental | Not described Receives: Drug: Low dose tenecteplase |
| High dose tenecteplase | Experimental | Not described Receives: Drug: High dose tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Before endovascular therapy
Favourable outcome: no symptomatic intracranial hemorrhage at 24-36 hours
No symptomatic intracranial hemorrhage at 24-36 hours
Measured: 24-36 hours
Secondary outcomes (13)
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography
Recanalization rate on CTA/MRA at 4-6 hours
Measured: 4-6 hours
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI
Infarct volume growth (ml) at 3-5 days on MRI
Measured: 3-5 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)
Measured: 24-36 hours
Clinical efficacy outcome: NIHSS change
NIHSS change at 24-36 hours as a continuous variable
Measured: 24-36 hours
Clinical efficacy outcome: excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days
Excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Measured: 90 days
Clinical efficacy outcome: good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days
Good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Measured: 90 days
Clinical efficacy outcome: modified Rankin scale shift
Modified Rankin scale shift at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Measured: 90 days
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours
Intracranial hemorrhage of any volume at 24-36 hours
Measured: 24-36 hours
Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours
Parenchymal hematoma 2 at 24-36 hours
Measured: 24-36 hours
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours
Symptomatic intracranial hemorrhage at 24-36 hours
Measured: 24-36 hours
Clinical safety outcome: Poor functional outcome (mRS 5, 6) at 90 days
Poor functional outcome (mRS 5, 6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Measured: 90 days
Clinical safety outcome: Rate of systemic bleeding
Rate of systemic bleeding within 24 hours
Measured: 24 hours
Barthel index
Barthel index at 90 days. The Barthel Index is a scale that indicates the ability to perform a selection of activities of daily living. It comprises 10 items (tasks), with total scores ranging from 0 (worst mobility in activities of daily living) to 100 (full mobility in activities of daily living) and it has adequate clinimetric (quality of clinical measurements) properties in stroke rehabilitation. In the index, the 10 items have these scoring combinations: a) 0 and 5, b) 0, 5 and 10, or c) 0, 5, 10 and 15. These items in the Barthel Index address a patient's ability in feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation and stair climbing.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start9 Dec 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, Ningbo No. 1 Hospital, Zhejiang Province People's Hospital, Shanghai 5th People's Hospital, Shanghai 10th People's Hospital, Shanghai 6th People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, The Second People's Hospital of Huai'an, Pu'er City People's Hospital, ShuGuang Hospital, Shanghai East Hospital, First People's Hospital of Shenyang
- Responsible party
- Principal investigator, Qiang Dong, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086147
- Sponsor's protocol ID
- 2017YFC1308201
- Acronym
- CHABLIS-T
- Status last verified
- Mar 2022
- First submitted
- 15 Apr 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41446320Hong 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.
PubMed 40497495Cheng 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.
PubMed 38286484
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Acute Tissue-based Imaging Selection for Lysis in Stroke: a Prospective, Multicentre, Randomized, Open-label, Rater-blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT04086147
- Acronym / sponsor ID
- CHABLIS-T / 2017YFC1308201
- Conditions
- Stroke
- Keywords
- acute ischemic stroke, large vessel occlusion, thrombolysis, tenecteplase, dosage, computed tomography, magnetic resonance imaging, diffusion weighted imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, Ningbo No. 1 Hospital, Zhejiang Province People's Hospital, Shanghai 5th People's Hospital, Shanghai 10th People's Hospital, Shanghai 6th People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, The Second People's Hospital of Huai'an, Pu'er City People's Hospital, ShuGuang Hospital, Shanghai East Hospital, First People's Hospital of Shenyang
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose tenecteplase | Experimental | Drug: Low dose tenecteplase |
| High dose tenecteplase | Experimental | Drug: High dose tenecteplase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose tenecteplaseIntravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg) | Drug | Low dose tenecteplase |
| High dose tenecteplaseIntravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg) | Drug | High dose tenecteplase |
Primary outcome
Favourable outcome: 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
Favourable outcome: 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
Favourable outcome: no symptomatic intracranial hemorrhage at 24-36 hours
Time frame: 24-36 hours
No symptomatic intracranial hemorrhage at 24-36 hours
13 secondary outcomes
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography
Time frame: 4-6 hours
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI
Time frame: 3-5 days
Clinical efficacy outcome: major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)
Time frame: 24-36 hours
Clinical efficacy outcome: NIHSS change
Time frame: 24-36 hours
Clinical efficacy outcome: excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days
Time frame: 90 days
Clinical efficacy outcome: good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days
Time frame: 90 days
Clinical efficacy outcome: modified Rankin scale shift
Time frame: 90 days
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours
Time frame: 24-36 hours
Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours
Time frame: 24-36 hours
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours
Time frame: 24-36 hours
Clinical safety outcome: Poor functional outcome (mRS 5, 6) at 90 days
Time frame: 90 days
Clinical safety outcome: Rate of systemic bleeding
Time frame: 24 hours
Barthel index
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 41446320Liu 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.
- Derived from this study: PubMed 40497495Hong 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.
- Derived from this study: PubMed 38286484Cheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose tenecteplase and High dose tenecteplase in people with Stroke, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favourable outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours (time frame: 4-6 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086147, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.