EXtending the Time Window for Thrombolysis in Posterior Circulation Stroke Without Early CT Signs
1 other identifier
interventional
234
1 country
27
Brief Summary
The primary hypothesis being tested in this trial is that ischemic stroke patients in posterior circulation at 4.5 - 24 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2022
27 active sites
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
June 19, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedStudy Start
First participant enrolled
August 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedDecember 18, 2024
February 1, 2023
2 years
June 19, 2022
December 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Independent recovery assessed by ratio of modified Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days
mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
90 ± 7 days
Secondary Outcomes (8)
Ordinal distribution of modified Rankin Scale (mRS) score at 90 ± 7 days
90 ± 7 days
Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days
90 ± 7 days
Major neurologic improvement (%) at 24 hours defined as an improvement on National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 points compared with the initial deficit or a score ≤ 1
24 hours
Major neurologic improvement (%) at 7 days defined as an improvement on National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 points compared with the initial deficit or a score ≤ 1
7 days
Symptomatic intracerebral hemorrhage (sICH) within 36 hours after randomization
within 36 hours
- +3 more secondary outcomes
Study Arms (2)
Alteplase with standard therapy
EXPERIMENTALPatients 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)
Standard therapy
NO INTERVENTIONStandard therapy
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients presenting with clinical signs of acute ischemic stroke between 4.5 and 24 hours from stroke onset, or wake-up stroke and unwitnessed stroke (if the midpoint of the last known well time is within 4.5 to 24 hours)
- Patients aged \> 18 years (or as per local requirements)
- NIHSS ≥ 1
- 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
- Pre-stroke mRS score \< 2
- Informed consent has been obtained from the patient, a family member, or a legally responsible person, depending on local ethics requirements
You may not qualify if:
- Intended to proceed to endovascular treatment
- 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
- 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
- Pregnancy, nursing, or unwillingness to use effective contraceptive measures during the trial period
- Likelihood of non-adherence to the trial protocol or follow-up
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
Related Publications (1)
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.
PMID: 40174223DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2022
First Posted
June 23, 2022
Study Start
August 17, 2022
Primary Completion
August 15, 2024
Study Completion
August 15, 2024
Last Updated
December 18, 2024
Record last verified: 2023-02