CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II (CHABLIS-T II)

November 24, 2023 updated by: Qiang Dong, Huashan Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients presenting with anterior circulation acute ischaemic stroke
  2. Time from onset to treatment 4.5h-24h
  3. Patient's age is >= 18 years，<= 80
  4. Pre-stroke mRS score of <= 2
  5. Clinically significant acute neurologic deficit
  6. Baseline National Institute of Health stroke scale >= 6
  7. Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
  8. 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
  9. Informed consent was obtained from patients.

Exclusion Criteria:

  1. Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
  2. Rapidly improving symptoms (patient with an NIHSS score decrease to < 4 at randomization)
  3. Pre-stroke mRS score of > 2
  4. Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
  5. Infarct core >1/3 middle cerebral artery (MCA) territory
  6. Platelet count < 100x10^9/L
  7. Symptoms were caused by low blood glucose < 2.7 mmol/l
  8. Severe uncontrolled hypertension, i.e. systolic blood pressure >= 180 mmHg or diastolic blood pressure >=100 mmHg
  9. Current use of warfarin with a prolonged prothrombin time (INR > 1.7 or prothrombin time > 15s)
  10. Use of low molecular weight heparin within 24 hours
  11. Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
  12. Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
  13. Arterial puncture at noncompressible site in previous 7 days
  14. Major surgery in previous 14 days which poses risk in the opinion of the investigator
  15. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
  16. Significant head trauma or prior stroke in previous 3 months
  17. History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
  18. Hereditary or acquired haemorrhagic diathesis
  19. Active internal bleeding
  20. Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
  21. Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
  22. Pregnancy or lactation
  23. Various dying diseases with life expectancy ≤3 months
  24. Other conditions in which doctors believe that participating in this study may be harmful to the patient
  25. Patients participated in any trial in 30 days
  26. Allergic to the test drug and its ingredients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tenecteplase arm
Drug: Tenecteplase
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
Other: Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
The best treatment selected by local doctors
Drug: The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Best treatment arm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Before endovascular therapy
no symptomatic intracranial hemorrhage at 24-36 hours
Time Frame: 24-36 hours
No symptomatic intracranial hemorrhage at 24-36 hours
24-36 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography
Time Frame: 4-6 hours
Recanalization rate on CTA/MRA at 4-6 hours
4-6 hours
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
Time Frame: 3-5 days
Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
3-5 days
Clinical efficacy outcome: NIHSS change
Time Frame: 24 hours (plus or minus 2 hours)
NIHSS change at 24 hours (plus or minus 2 hours)
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)
Time Frame: 90 days (plus or minus 7 days)
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)
Clinical efficacy outcome: percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)
Time Frame: 90 days (plus or minus 7 days)
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
Time Frame: 90 days (plus or minus 7 days)
Incident vascular event within 90 days (ischemic stroke/ hemorrhagic stroke/ cardiac infarct/ cardiac or brain revascularization (including Carotid Endarterectomy, Intracranial and Extracranial Artery Intervention, Intracranial and extracranial artery bypass, and Coronary artery intervention or bypass graft))
90 days (plus or minus 7 days)
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours
Time Frame: 24-36 hours
Intracranial hemorrhage of any volume at 24-36 hours
24-36 hours
Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours
Time Frame: 24-36 hours
Parenchymal hematoma 2 at 24-36 hours
24-36 hours
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours
Time Frame: 24-36 hours
Symptomatic intracranial hemorrhage at 24-36 hours
24-36 hours
Clinical safety outcome: death within 90 days
Time Frame: 90 days (plus or minus 7 days)
Death within 90 days (plus or minus 7 days)
90 days (plus or minus 7 days)
Clinical safety outcome: Rate of systemic bleeding
Time Frame: 90 days (plus or minus 7 days)
Rate of systemic bleeding within 90 days (plus or minus 7 days)
90 days (plus or minus 7 days)
Barthel index
Time Frame: 90 days (plus or minus 7 days)
Barthel index at 90 days (plus or minus 7 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.
90 days (plus or minus 7 days)
Imaging efficacy 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 without Parenchymal hematoma 2
4-6 hours
Imaging efficacy 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 Parenchymal hematoma 2
Before endovascular therapy
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days
Time Frame: 3-5 days
Recanalization rate on CTA/MRA at 3-5 days
3-5 days
Clinical efficacy outcome: NIHSS change at 7 days
Time Frame: 7 days (plus or minus 2 days)
NIHSS change at 7 days (plus or minus 2 days)
7 days (plus or minus 2 days)
Clinical efficacy outcome: vascular death within 90 days
Time Frame: 90 days (plus or minus 7 days)
Vascular death within 90 days (plus or minus 7 days) (stroke, cardiac infarct, pulmonary embolism)
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)
Time Frame: 24-36 hours
Major neurological improvement at 24-36 hours ( NIHSS reduction >8 or return to 0-1)
24-36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huashan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai 10th People's Hospital
Shanghai East Hospital
Zhejiang University
The Second Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Shanxi Medical University
Ningbo No. 1 Hospital
Huizhou Municipal Central Hospital
First Affiliated Hospital of Harbin Medical University
Shanghai 6th People's Hospital
Linyi People's Hospital
Zhejiang Province People's Hospital
Nanshi Hospital of Nanyang
Shanghai Fifth People's Hospital,Fudan University
the Third Hospital of Mianyang
Puer People's Hospital
Hexigten Traditional Chinese and Mongolian Medicine Hospital
Yangpu Hospital, School of Medicine, Tongji University
Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine
Xuzhou Medical University Affiliated Hospital of Huaian
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
The First Affiliated Hospital of Soochow Medical University
Affiliated Haian People's Hospital of Nantong University
The Central Hospital of Jiaozuo Coal Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHDC2020CR1041B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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