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Ischemic Stroke, AcutePhase 3TRACE-5NCT06196320

Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5

A Phase 3 study testing Tenecteplase and Best Practice (which may include intravenous Alteplase) in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 59 sites in China.

Completed

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

Official record
Search all trials

Trial summary

The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting within 24 hours will be randomized 1:1 to intravenous tenecteplase (0.25mg/kg, maximum 25mg) ± thrombectomy or 'best… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Acute
What is being tested?
Tenecteplase and Best Practice (which may include intravenous Alteplase)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
59 sitesChina
Study dates
24 Jan 2024to 22 Sep 2025
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

  • Age ≥18.
  • Patients presenting with posterior circulation ischemic stroke symptoms due to near-complete or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well.
  • Presence of a basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a near or complete occlusion.
  • Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
  • Local legal requirements for consent have been satisfied.

Who cannot join

  • Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
  • Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) <6 on non-contrast CT (NCCT) or CTA-source images or MRI diffusion weighted imaging (DWI).
  • Significant cerebellar mass effect or acute hydrocephalus.
  • Established frank hypodensity on non-contrast CT indicating subacute infarction.
  • Bilateral extensive brainstem ischemia.
  • Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
Show all 14Show fewer
  • Other standard contraindications to intravenous thrombolysis.
  • Contraindication to imaging with contrast agents.
  • Clinically evident pregnant women.
  • Vessel imaging showing both anterior and posterior circulation large vessel occlusion.
  • Current participation in another research drug treatment protocol.
  • Known terminal illness such that the patients would not be expected to survive a year.
  • Planned withdrawal of care or comfort care measures.
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

China59 sites

  • Huaxian People's Hospital of Henan

    Anyang, Henan

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • Beijing Daxing District People's Hospital

    Beijing

  • Jilin Electric Power Hospital

    Changchun, Jilin

  • Chenzhou First People's Hospital

    Chenzhou, Hunan

  • The Fourth People's Hospital of Chenzhou

    Chenzhou, Hunan

  • The Second People's Hospital of Dongying

    Dongying, Shandong

  • Taihe County Traditional Chinese Medicine Hospital

    Fuyang, Anhui

  • Gaomi People's Hospital

    Gaomi, Shandong

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • The Second People's Hospital of Guiyang

    Guiyang, Guizhou

  • Haikou People's Hospital

    Haikou, Hainan

  • Qiu County People's Hospital

    Handan, Hebei

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Lixin County People's Hospital

    Haozhou, Anhui

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Hengyang Central Hospital

    Hengyang, Hunan

  • Heyuan People's Hospital

    Heyuan, Guangdong

  • Huazhou People's Hospital

    Huazhou, Guangdong

  • Jiaozuo Coal Industry Central Hospital

    Jiaozuo, Henan

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

  • Jiujiang First People's Hospital

    Jiujiang, Jiangxi

  • Keshketeng Banner Chinese-Mongolian Hospital

    Keshketeng Banner, Inner Mongolia

  • Laizhou City People's Hospital

    Laizhou, Shandong

  • Linfen Central Hospital

    Linfen, Shanxi

  • The First People Hospital of Lingbao

    Lingbao, Henan

  • Linyi People's Hospital

    Linyi, Shandong

  • Liuyang Jili Hospital

    Liuyang, Henan

  • Nanshi Hospital of Nanyang

    Nanyang, Henan

  • Ningbo Beilun District People's Hospital

    Ningbo, Zhejiang

  • Nanle County People's Hospital

    Puyang, Henan

  • Nanle Zhongxing Hospital

    Puyang, Henan

  • Puyang Oilfield General Hospital

    Puyang, Henan

  • Qiandongnanzhou People's Hospital

    Qiandongnan, Guizhou

  • Qingdao Municipal Hospital

    Qingdao, Shandong

  • The Second Hospital of Qinhuangdao

    Qinhuangdao, Hebei

  • Shaoguan Qujiang District People's Hospital

    Shaoguan, Guangdong

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning

  • Hongxinglong Hospital of Beidahuang Group

    Shuangyashan, Heilongjiang

  • Siping City Central People's Hospital

    Siping, Jilin

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong

  • Tangshan Guye Traditional Chinese Medicine Hospital

    Tangshan, Hebei

  • First People's Hospital of Tianshui

    Tianshui, Gansu

  • Liuhe County People's Hospital

    Tonghua, Jilin

  • Tongliao People's Hospital

    Tongliao, Inner Mongolia

  • The Affiliated Hospital of Shandong Second Medical University

    Weifang, Shandong

  • Weifang People's Hospital

    Weifang, Shandong

  • Weihai Central Hospital

    Weihai, Shandong

  • Qinghe County People's Hospital

    Xingtai, Hebei

  • Guangshan County People's Hospital

    Xinyang, Henan

  • Xi County People's Hospital

    Xinyang, Henan

  • Yantai Taochun Central Hospital

    Yantai, Shandong

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong

  • Taikang Xian People's Hospital

    Zhoukou, Henan

  • People's Hospital of Queshan

    Zhumadian, Henan

  • Zhumadian Traditional Chinese Medicine Hospital

    Zhumadian, Henan

Other trials in China

About this study

Official title: Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5 Improving Neurological Functional Outcomes in Basilar Artery Occlusion With Tenecteplase in Extended Time Window: Multicentre, Prospective, Open-label, Blinded Endpoint (PROBE), Phase 3, Randomized Controlled Trial

The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting within 24 hours will be randomized 1:1 to intravenous tenecteplase (0.25mg/kg, maximum 25mg) ± thrombectomy or 'best practice'which may be alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion.

Read the detailed description

The study will be a multicentre, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial (2 arm with 1:1 randomization) in patients with acute ischemic stroke due to basilar artery occlusion presenting to hospital within 24 hours of symptom onset.

Patients will be required to have complete or near-complete occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA), defined as 'potentially retrievable' thrombus in the basilar artery. Thrombectomy is permitted within 24 hours as part of standard care but is not mandatory.

Patients will be randomized to treatment with either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg within 4.5 hours from stroke onset) or intravenous tenecteplase (0.25mg/kg, maximum 25mg). Time of onset of symptoms is defined as described by the patient or witness; if unknown, it is considered to be the last time the patient was seen well. In patients presenting with mild (e.g. vertigo, dizziness, headache, diplopia, dysarthria) stuttering symptoms followed by sudden onset of clinical deterioration with decrease in conscious state or moderate to severe motor deficits, the time of deterioration in clinical state is taken as the estimated time of basilar artery occlusion.

Being tested
Tenecteplase, Best Practice (which may include intravenous Alteplase)
Keywords
rhTNK-tPA, rt-PA, Ischemic stroke, phase III trial, basilar artery occlusion
Medical subject headings
Ischemic Stroke

What participants receive

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

  • TenecteplaseDrug

    Also called rhTNK-tPA, TNK-tPA

    Intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) within 24 hours ± thrombectomy at treating clinician's discretion

  • Best Practice (which may include intravenous Alteplase)Drug

    Also called rt-PA

    Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion

Study groups in NCT06196320
Study groupRoleWhat they receive
TenecteplaseExperimentalIntravenous tenecteplase (0.25mg/kg, maximum 25mg) within 24 hours ± thrombectomy at treating clinician's discretion
Receives: Drug: Tenecteplase
Best Practice (which may include intravenous Alteplase)Active comparatorIntravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
Receives: Drug: Best Practice (which may include intravenous Alteplase)

What is being measured

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

  1. Modified Rankin Scale (mRS) 0-1 or return to baseline mRS

    The proportion of patients with Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS (if baseline premorbid mRS =2-3) at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

    Measured: 3 months

Secondary outcomes (10)

  1. Modified Rankin Scale (mRS) 0-2 or return to baseline mRS

    Proportion of patients with Modified Rankin Scale (mRS) 0-2 or return to baseline mRS at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

    Measured: 3 months

  2. Modified Rankin Scale (mRS) 0-3 or return to baseline mRS

    Proportion of patients with Modified Rankin Scale (mRS) 0-3 or return to baseline mRS at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

    Measured: 3 months

  3. Ordinal analysis of the Modified Rankin Scale (mRS)

    Ordinal analysis of the Modified Rankin Scale (mRS), merging category 5-6, at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

    Measured: 3 months

  4. Early neurological improvement

    Proportion of patients achieving early clinical improvement (reduction in acute - 72 hour National Institutes of Health Stroke Scale [NIHSS] score of ≥8 or 72 hour NIHSS 0-1).

    Measured: 72 hours

  5. Successful reperfusion

    Proportion of patients with complete occlusion at baseline who achieve expanded Thrombolysis In Cerebral Infarction score (eTICI) 2b/3 on initial digital subtraction angiography (DSA) run prior to thrombectomy.

    Measured: initial DSA run prior to thrombectomy

  6. Symptomatic intracranial hemorrhage (sICH)

    Proportion of patients with symptomatic intracranial hemorrhage (sICH) defined as local or remote parenchymal hemorrhage type 2 (PH2) on the 22-36 hours post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 hours, or leading to death.

    Measured: 36 hours

  7. All-cause mortality

    All-cause mortality within 90 days.

    Measured: 90 days

  8. Severe disability or death

    Proportion of patients with Modified Rankin Scale (mRS) 5-6 at 90 days (severe disability or death). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

    Measured: 90 days

  9. Clinical deterioration

    Proportion of patients with partially occlusive thrombus at baseline who have clinical deterioration within 24 hours leading to further treatment (e.g. endovascular thrombectomy).

    Measured: 24 hours

  10. Vessel recanalization

    Vessel recanalization rate evaluated by CT or MR angiography within 24+/-6 hours (if performed).

    Measured: 24+/-6 hours

Timeline

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

  1. First posted9 Jan 2024
  2. Study start24 Jan 2024
  3. Primary completion11 Sep 2025
  4. Study completion22 Sep 2025

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
Single blind
Who is masked
Outcomes assessor
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196320
Sponsor's protocol ID
CSA2023YJ002
Acronym
TRACE-5
Status last verified
Apr 2025
First submitted
6 Dec 2023
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xiong Y, Alemseged F, Cao Z, Schwamm LH, Zhang S, Parsons MW, Fisher M, Hao Y, Jin A, Yin J, Jiang Y, Che F, Wang L, Zhou L, Dai H, Zhao Y, Duan C, Wu S, Feng G, Zong L, Ye W, Wang Z, Xu Z, Wang H, Hao M, Ma Y, Meng X, Li H, Li Z, Wang Y, Liu L, Zhao X, Campbell BCV, Wang Y; TRACE-5 investigators. Tenecteplase versus standard medical treatment for basilar artery occlusion within 24 h (TRACE-5): a multicentre, prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial. Lancet. 2026 Feb 21;407(10530):763-772. doi: 10.1016/S0140-6736(25)02633-9. Epub 2026 Feb 5.

    PubMed 41655588

  • Xiong Y, Alemseged F, Cao Z, Schwamm LH, Parsons M, Fisher M, Wu S, Campbell BCV, Wang Y. Tenecteplase versus standard care in patients with acute basilar artery occlusion: a multi-centre, prospective, randomised, open-label, blinded endpoint, phase 3, controlled trial. Stroke Vasc Neurol. 2026 Jun 29;11(3):365-372. doi: 10.1136/svn-2025-004432.

    PubMed 41151803

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenecteplase and Best Practice (which may include intravenous Alteplase) in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 59 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 5 inclusion and 14 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 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?

Modified Rankin Scale (mRS) 0-1 or return to baseline mRS (time frame: 3 months). 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 NCT06196320, which also lists 2 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 26 Nov 2025.

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