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Stroke, Acute IschemicPhase 3NCT05429476

EXtending the Time Window for Thrombolysis in Posterior Circulation Stroke Without Early CT Signs

A Phase 3 study testing Tissue Plasminogen Activator (Alteplase) in people with Stroke, Acute Ischemic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 27 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute Ischemic
What is being tested?
Tissue Plasminogen Activator (Alteplase)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
27 sitesChina
Study dates
17 Aug 2022to 15 Aug 2024
Phase
Phase 3
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 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
  • 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
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Any condition that, in the judgment of the investigator, could impose hazards if study therapy is initiated or affect patient participation in the study
  • Participation in other interventional clinical trials within the previous 3 months
  • A life expectancy of less than three months
  • The judgment is left to the discretion of the investigator

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • People's Hospital of Anji

    Anji

  • Botou City Hospital

    Botou

  • Dongyang Affiliated Hospital of Wenzhou Medical University

    Dongyang

  • Haiyan People's Hospital

    Haiyan

  • Hangzhou First People's Hospital

    Hangzhou

  • Second Affiliated Hospital of Zhejiang University, School of Medicine

    Hangzhou

  • Huzhou Central Hospital

    Huzhou

  • Huzhou First People's Hospital

    Huzhou

  • Nanxun District People's Hospital

    Huzhou

  • South Taihu Hospital Affiliated to Huzhou College

    Huzhou

  • The First People's Hospital Jiashan

    Jiashan

  • First Affiliated Hospital of Jiaxing University

    Jiaxing

  • Jiaxing Hospital of T.C.M

    Jiaxing

  • Second Affiliated Hospital of Jiaxing University

    Jiaxing

  • Affiliated Jinhua Hospital, Zhejiang University School of Medicine

    Jinhua

  • Longyan First Hospital

    Longyan

  • Rui'an People's Hospital

    Rui’an

  • China Medical University Shaoxing Hospital

    Shaoxing

  • Shengzhou People's Hospital

    Shengzhou

  • Taizhou Central Hospital

    Taizhou

  • Taizhou Hospital of Zhejiang Province

    Taizhou

  • The First People's Hospital of Wenling

    Wenling

  • Yongjia People's Hospital

    Yongjia

  • Yueqing People's Hospital

    Yueqing

  • Zhejiang Hospital

    Zhejiang

  • The First People's Hospital Daishan

    Zhoushan

  • Zhuji Affiliated Hospital of Wenzhou Medical University

    Zhuji

Other trials in China

About this study

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.

Read the detailed description

Posterior circulation stroke accounts for 20-25% of all ischemic strokes, with an annual adjusted incidence of 18 per 100,000 person-years. Compared with anterior circulation stroke, posterior circulation stroke is less studied and has poor neurological outcomes, which requires attention. Intravenous thrombolytic therapy has greatly improved the rate of recanalization and reperfusion in patients with acute ischemic stroke, increased the proportion of patients with good prognosis, and reduced mortality. Guidelines recommend intravenous thrombolysis within 4.5 hours of onset or awakening in patients with ischemic stroke. However, the proportion of posterior circulation stroke is low or unreported in most randomized controlled trials, such as 5% of patients in the NINDS study, so it may be inappropriate to apply the results of these trials directly to patients with posterior circulation ischemic stroke.

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.

Being tested
Tissue Plasminogen Activator (Alteplase)
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tissue Plasminogen Activator (Alteplase)Drug

    Also called actilyse, activase, tPA, r-tPA

    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

Study groups in NCT05429476
Study groupRoleWhat they receive
Alteplase with standard therapyExperimentalPatients 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)
Receives: Drug: Tissue Plasminogen Activator (Alteplase)
Standard therapyNo interventionStandard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 ± 7 days

Secondary outcomes (8)

  1. Ordinal distribution of modified Rankin Scale (mRS) score at 90 ± 7 days

    mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

    Measured: 90 ± 7 days

  2. Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days

    mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

    Measured: 90 ± 7 days

  3. 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

    NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms

    Measured: 24 hours

  4. 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

    NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms

    Measured: 7 days

  5. Symptomatic intracerebral hemorrhage (sICH) within 36 hours after randomization

    sICH as defined by The European Cooperative Acute Stroke Study III criteria [ECASSIII]

    Measured: within 36 hours

  6. Parenchymal hematoma (PH) (%) within 36 hours after randomization

    PH as defined by the European Cooperative Acute Stroke Study [ECASS] criteria

    Measured: within 36 hours

  7. Any intracerebral hemorrhage (ICH) within 36 hours after randomization

    Measured: within 36 hours

  8. Mortality (%) within 90 days

    Mortality refers to rate of death from any cause

    Measured: within 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start17 Aug 2022
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05429476
Sponsor's protocol ID
EXPECTS
Status last verified
Feb 2023
First submitted
19 Jun 2022
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40174223

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tissue Plasminogen Activator (Alteplase) in people with Stroke, Acute Ischemic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 27 sites 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 7 inclusion and 19 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Independent recovery assessed by ratio of modified Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days (time frame: 90 ± 7 days). 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 NCT05429476, which also lists 1 linked publication.

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 18 Dec 2024.

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