StrokePhase 2CHABLIS-T IINCT04516993
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
A Phase 2 study testing Tenecteplase and The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) in people with Stroke, run by Huashan Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Tenecteplase and The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2021to 30 Sep 2023
- 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 to 80 years
- 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，<= 80
- Pre-stroke mRS score of <= 2
- Clinically significant acute neurologic deficit
- Baseline National Institute of Health stroke scale >= 6
Show all 9Show fewer
- 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 or lactation
- 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 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: 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
- Conditions
- Stroke
- Being tested
- Tenecteplase, The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
- 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.
TenecteplaseDrug
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)Drug
Best treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase arm | Experimental | Not described Receives: Drug: Tenecteplase |
| Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) | Other | The best treatment selected by local doctors Receives: Drug: The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
no symptomatic intracranial hemorrhage at 24-36 hours
No symptomatic intracranial hemorrhage at 24-36 hours
Measured: 24-36 hours
Secondary outcomes (18)
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 or CT perfusion
Infarct volume growth (ml) at 3-5 days on MRI or CT perfusion
Measured: 3-5 days
Clinical efficacy outcome: NIHSS change
NIHSS change at 24 hours (plus or minus 2 hours)
Measured: 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)
percent of excellent functional outcome (modified Rankin scale 0-1) at 90 days (plus or minus 7 days)
Measured: 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)
percent of good functional outcome (modified Rankin scale 0-2) at 90 days (plus or minus 7 days)
Measured: 90 days (plus or minus 7 days)
Clinical efficacy outcome: incident event
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))
Measured: 90 days (plus or minus 7 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: death within 90 days
Death within 90 days (plus or minus 7 days)
Measured: 90 days (plus or minus 7 days)
Clinical safety outcome: Rate of systemic bleeding
Rate of systemic bleeding within 90 days (plus or minus 7 days)
Measured: 90 days (plus or minus 7 days)
Barthel index
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.
Measured: 90 days (plus or minus 7 days)
Imaging efficacy 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 without Parenchymal hematoma 2
Measured: 4-6 hours
Imaging efficacy 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 Parenchymal hematoma 2
Measured: Before endovascular therapy
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days
Recanalization rate on CTA/MRA at 3-5 days
Measured: 3-5 days
Clinical efficacy outcome: NIHSS change at 7 days
NIHSS change at 7 days (plus or minus 2 days)
Measured: 7 days (plus or minus 2 days)
Clinical efficacy outcome: vascular death within 90 days
Vascular death within 90 days (plus or minus 7 days) (stroke, cardiac infarct, pulmonary embolism)
Measured: 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)
Major neurological improvement at 24-36 hours ( NIHSS reduction >8 or return to 0-1)
Measured: 24-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start28 Sep 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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.
- 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
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Puer People's Hospital, Shanghai 6th People's Hospital, Hexigten Traditional Chinese and Mongolian Medicine Hospital, Yangpu Hospital, School of Medicine, Tongji University, The First Affiliated Hospital of Shanxi Medical University, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Linyi People's Hospital, Shanghai 10th People's Hospital, Nanyang Nanshi Hospital, Fudan University, Xuzhou Medical University Affiliated Hospital of Huaian, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, The First Affiliated Hospital of Soochow University, Affiliated Haian People's Hospital of Nantong University, First Affiliated Hospital of Harbin Medical University, the Third Hospital of Mianyang, Zhejiang Province People's Hospital, Shanghai East Hospital, The Central Hospital of Jiaozuo Coal Group, Huizhou Municipal Central Hospital, Zhejiang University, The Second Affiliated Hospital of Chongqing Medical University, Ningbo No. 1 Hospital
- Responsible party
- Principal investigator, Qiang Dong, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516993
- Sponsor's protocol ID
- SHDC2020CR1041B
- Acronym
- CHABLIS-T II
- Status last verified
- Nov 2023
- First submitted
- 14 Aug 2020
- Last updated
- 29 Nov 2023
- 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, Lin L, Churilov L, Ling Y, Yang N, Fu J, Lu G, Yue Y, Zhang J, Wang F, Wang Z, Zhao Y, Zhou X, Peng Z, Wu D, Zhao L, Zhai Q, Yu X, Fang Q, Shao X, Tang Y, Zhang D, Geng Y, Zhang Y, Fan B, Zhang B, Yin C, Chen Y, Zhang Y, Liu X, Li S, Yang L, Parsons M, Dong Q; CHABLIS-T II Collaborators. Tenecteplase Thrombolysis for Stroke up to 24 Hours After Onset With Perfusion Imaging Selection: The CHABLIS-T II Randomized Clinical Trial. Stroke. 2025 Feb;56(2):344-354. doi: 10.1161/STROKEAHA.124.048375. Epub 2025 Jan 2.
PubMed 39744861
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04516993
- Acronym / sponsor ID
- CHABLIS-T II / SHDC2020CR1041B
- 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
- 224 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Puer People's Hospital, Shanghai 6th People's Hospital, Hexigten Traditional Chinese and Mongolian Medicine Hospital, Yangpu Hospital, School of Medicine, Tongji University, The First Affiliated Hospital of Shanxi Medical University, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Linyi People's Hospital, Shanghai 10th People's Hospital, Nanyang Nanshi Hospital, Fudan University, Xuzhou Medical University Affiliated Hospital of Huaian, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, The First Affiliated Hospital of Soochow University, Affiliated Haian People's Hospital of Nantong University, First Affiliated Hospital of Harbin Medical University, the Third Hospital of Mianyang, Zhejiang Province People's Hospital, Shanghai East Hospital, The Central Hospital of Jiaozuo Coal Group, Huizhou Municipal Central Hospital, Zhejiang University, The Second Affiliated Hospital of Chongqing Medical University, Ningbo No. 1 Hospital
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Aug 2020 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase arm | Experimental | Drug: Tenecteplase |
| Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) | Other | Drug: The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)The best treatment selected by local doctors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| TenecteplaseIntravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg) | Drug | Tenecteplase arm |
| The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)Best treatment arm | Drug | Best treatment arm (e.g. Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) |
Primary 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
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
18 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 or CT perfusion
Time frame: 3-5 days
Clinical efficacy outcome: NIHSS change
Time frame: 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)
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)
Clinical efficacy outcome: incident event
Time frame: 90 days (plus or minus 7 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: death within 90 days
Time frame: 90 days (plus or minus 7 days)
Clinical safety outcome: Rate of systemic bleeding
Time frame: 90 days (plus or minus 7 days)
Barthel index
Time frame: 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
Imaging efficacy outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram
Time frame: Before endovascular therapy
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography at 3-5 days
Time frame: 3-5 days
Clinical efficacy outcome: NIHSS change at 7 days
Time frame: 7 days (plus or minus 2 days)
Clinical efficacy outcome: vascular death within 90 days
Time frame: 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
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 29 Nov 2023.
- 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 39744861Cheng X, Hong L, Lin L, Churilov L, Ling Y, Yang N, Fu J, Lu G, Yue Y, Zhang J, Wang F, Wang Z, Zhao Y, Zhou X, Peng Z, Wu D, Zhao L, Zhai Q, Yu X, Fang Q, Shao X, Tang Y, Zhang D, Geng Y, Zhang Y, Fan B, Zhang B, Yin C, Chen Y, Zhang Y, Liu X, Li S, Yang L, Parsons M, Dong Q; CHABLIS-T II Collaborators. Tenecteplase Thrombolysis for Stroke up to 24 Hours After Onset With Perfusion Imaging Selection: The CHABLIS-T II Randomized Clinical Trial. Stroke. 2025 Feb;56(2):344-354. doi: 10.1161/STROKEAHA.124.048375. Epub 2025 Jan 2.
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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 Tenecteplase and The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy) 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 9 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 29 Nov 2023. 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?
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 NCT04516993, 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 29 Nov 2023.