EXtending the Time Window for Thrombolysis in Posterior Circulation Stroke Without Early CT Signs
NCT ID: NCT05429476
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2022-08-17
2024-08-15
Brief Summary
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Detailed Description
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Multiple studies have also shown a lower risk of post-circulation bleeding complications compared to pre-circulation stroke. A meta-analysis of patients with posterior circulation ischemic stroke (11.9% of posterior circulation stroke) showed that posterior circulation stroke had a lower risk of intracranial hemorrhage due to intravenous thrombolysis, half the risk of anterior circulation stroke, and a higher 3-month good functional outcome. The lower risk of hemorrhagic transformation in posterior circulation stroke is due to the greater tolerance of the posterior circulation area to ischemic injury, possibly due to a greater proportion of white matter and arterial collaterals, especially in the brainstem. In addition, the smaller infarct size of posterior circulation stroke compared with anterior circulation stroke also reduced the risk of bleeding in these patients.
Therefore, the purpose of this study was to investigate whether patients with posterior circulation stroke with onset or discovery time of 4.5-24 hours could benefit from intravenous thrombolysis in the Chinese population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Alteplase with standard therapy
Patients will receive standard dose intravenous alteplase (0.9 mg per kilogram, the first 10% administered as an initial bolus and the remainder over a 1-hour period, with a maximum dose of 90 mg)
Tissue Plasminogen Activator (Alteplase)
Tissue Plasminogen Activator (Alteplase) 0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour
Other Names:
Actilyse Activase tPA r-tPA
Standard therapy
Standard therapy
No interventions assigned to this group
Interventions
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Tissue Plasminogen Activator (Alteplase)
Tissue Plasminogen Activator (Alteplase) 0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour
Other Names:
Actilyse Activase tPA r-tPA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients aged \> 18 years (or as per local requirements)
3. NIHSS ≥ 1
4. Patients with a posterior circulation ASPECT score (PC-ASPECTS) ≥ 7. If MRI is performed first and the PC-ASPECTS on diffusion-weighted imaging (DWI) is ≥ 7, a non-contrast head CT is not required. If PCASPECTS on DWI is \< 7, the subsequent non-contrast CT must show a PC-ASPECTS ≥ 7 for inclusion
5. Posterior circulation stroke confirmation criteria: If MRI is performed, infarction confirmed by DWI is sufficient. If CT is performed, the non-contrast CT scan must not refute posterior circulation stroke, and clinical signs and symptoms must support the diagnosis, as confirmed by experienced clinicians. If clinical symptoms are atypical, CTA showing symptomatic stenosis or occlusion of large posterior circulation vessels, or CT perfusion showing symptomatic hypoperfusion, can provide additional evidence, though advanced imaging is not mandatory
6. Pre-stroke mRS score \< 2
7. Informed consent has been obtained from the patient, a family member, or a legally responsible person, depending on local ethics requirements
Exclusion Criteria
2. Contraindications for alteplase:
* Allergy to alteplase
* Rapidly improving symptoms at the discretion of the investigator
* The presence of epileptic seizures, hemiplegia after seizures (Todd's palsy), or other neurological/mental illnesses that prevent cooperation or willingness to participate
* Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg) despite treatment
* Blood glucose levels outside the acceptable range (\<2.8 mmol/L or \>22.2 mmol/L), with point-of-care glucose testing considered valid
* High risk of bleeding due to active internal bleeding, major surgery, trauma, gastrointestinal, or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
* Known impairments in coagulation due to comorbid disease or anticoagulant use, including an INR \>1.7 or prothrombin time \>15 seconds for those on warfarin, recent use of direct thrombin inhibitors or direct factor Xa inhibitors without reversal capability, or full-dose heparin/heparinoid within the last 24 hours with an aPTT above normal limits
* Known defect in platelet function or a platelet count below 100,000/mm³
* History of ischemic stroke, myocardial infarction, intracranial hemorrhage, severe traumatic brain injury, or intraspinal operation within the previous 3 months, or known intracranial neoplasm, arteriovenous malformation, or giant aneurysm
* Acute or past intracerebral hemorrhage identified by CT or MRI
3. Infarction of the anterior circulation confirmed by MRI, or vascular examination indicating occlusion of large anterior circulation vessels, or perfusion imaging showing hypoperfusion changes in the anterior circulation area
4. Pregnancy, nursing, or unwillingness to use effective contraceptive measures during the trial period
5. Likelihood of non-adherence to the trial protocol or follow-up
6. Any condition that, in the judgment of the investigator, could impose hazards if study therapy is initiated or affect patient participation in the study
7. Participation in other interventional clinical trials within the previous 3 months
8. A life expectancy of less than three months
9. The judgment is left to the discretion of the investigator
18 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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People's Hospital of Anji
Anji, , China
Botou City Hospital
Botou, , China
Dongyang Affiliated Hospital of Wenzhou Medical University
Dongyang, , China
Haiyan People's Hospital
Haiyan, , China
Hangzhou First People's Hospital
Hangzhou, , China
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, , China
Huzhou Central Hospital
Huzhou, , China
Huzhou First People's Hospital
Huzhou, , China
Nanxun District People's Hospital
Huzhou, , China
South Taihu Hospital Affiliated to Huzhou College
Huzhou, , China
The First People's Hospital Jiashan
Jiashan, , China
First Affiliated Hospital of Jiaxing University
Jiaxing, , China
Jiaxing Hospital of T.C.M
Jiaxing, , China
Second Affiliated Hospital of Jiaxing University
Jiaxing, , China
Affiliated Jinhua Hospital, Zhejiang University School of Medicine
Jinhua, , China
Longyan First Hospital
Longyan, , China
Rui'an People's Hospital
Rui’an, , China
China Medical University Shaoxing Hospital
Shaoxing, , China
Shengzhou People's Hospital
Shengzhou, , China
Taizhou Central Hospital
Taizhou, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
The First People's Hospital of Wenling
Wenling, , China
Yongjia People's Hospital
Yongjia, , China
Yueqing People's Hospital
Yueqing, , China
Zhejiang Hospital
Zhejiang, , China
The First People's Hospital Daishan
Zhoushan, , China
Zhuji Affiliated Hospital of Wenzhou Medical University
Zhuji, , China
Countries
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References
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Yan S, Zhou Y, Lansberg MG, Liebeskind DS, Yuan C, Yu H, Chen F, Chen H, Zhang B, Mao L, Zhang X, Wang X, Zhang X, Chen Y, Zhou H, Zhong W, He Y, Chen K, Wang J, Chen H, Huang Y, Campbell BCV, Lou M; EXPECTS Group. Alteplase for Posterior Circulation Ischemic Stroke at 4.5 to 24 Hours. N Engl J Med. 2025 Apr 3;392(13):1288-1296. doi: 10.1056/NEJMoa2413344.
Other Identifiers
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EXPECTS
Identifier Type: -
Identifier Source: org_study_id