AzTrials
AzTrials

Ischemic Stroke, AcutePhase 3TRACE IIINCT05141305

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III

A Phase 3 study testing tenecteplase (0.25 mg/kg, Max 25 mg) and standard medical treatment in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 1 site 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 phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to anterior circulation large vessel occlusion within 4.5-24 hours from last known well (including wake-up stroke and unwitnessed stroke) will be randomized 1:1… 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 (0.25 mg/kg, Max 25 mg) and standard medical treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 siteChina
Study dates
19 Jan 2022to 9 Feb 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

  • Age ≥18 years old;
  • Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrolment; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
  • Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA, internal carotid artery, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;
  • Pre-stroke modified Rankin scale (mRS) score≤1;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);
  • Neuroimaging: target mismatch profile on CTP or MRI+MR Perfusion (ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;
  • Written informed consent from patients or their legally authorized representatives.

Who cannot join

  • Intended to proceed to endovascular treatment;
  • Allergy to tenecteplase;
  • Rapidly improving symptoms at the discretion of the investigator;
  • NIHSS consciousness score 1a >2, or epileptic seizure, hemiplegia after seizures ( Todd's palsy ) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate;
  • Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg), despite blood pressure-lowering treatment;
  • Blood glucose <2.8 or >22.2 mmol/L (point of care glucose testing is acceptable );
Show all 19Show fewer
  • Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days;
  • Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR >1.7 or prothrombin time >15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an elevated aPTT greater than the upper limit of normal;
  • Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included);
  • Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation or giant aneurysm;
  • Any terminal illness such that the patient would not be expected to survive more than 1 year;
  • Unable to perform CTP or PWI;
  • Hypodensity in >1/3 MCA territory on non-contrast CT;
  • Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI;
  • Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);
  • Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial;
  • Unlikely to adhere to the trial protocol or follow-up;
  • 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;
  • Participation in other interventional clinical trials within the previous 3 months.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: A Phase 3, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion With Perfusion Mismatch up to 24 Hours of Symptom Onset

The trial is a phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to anterior circulation large vessel occlusion within 4.5-24 hours from last known well (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.

Read the detailed description

The study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE), controlled phase 3 trial (2 arms with 1:1 randomization) in ischemic stroke due to anterior circulation large vessel occlusion with perfusion mismatch up to 24 hours of symptom onset. The target mismatch profiles on CTP or MRI perfusion weighted imaging include ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL demonstrated by a certified automatic software. The minimum sample size is 516 patients.

Being tested
tenecteplase (0.25 mg/kg, Max 25 mg), standard medical treatment
Keywords
tenecteplase, alteplase, ischemic stroke, phase 3 trial
Medical subject headings
Ischemic Stroke

What participants receive

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

  • tenecteplase (0.25 mg/kg, Max 25 mg)Drug

    tenecteplase (0.25 mg/kg) is being used.

  • standard medical treatmentDrug

    Also called Aspirin, Clopidogrel

    Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone are being used.

Study groups in NCT05141305
Study groupRoleWhat they receive
tenecteplase ( 0.25 mg/kg, Max 25 mg )ExperimentalTenecteplase (0.25 mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.
Receives: Drug: tenecteplase (0.25 mg/kg, Max 25 mg)
standard medical treatmentActive comparatorAspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of local investigators.
Receives: Drug: standard medical treatment

What is being measured

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

  1. Excellent functional outcome

    Proportion of excellent functional outcome defined as an mRS score ≤ 1 at 90 days

    Measured: 90 days

Secondary outcomes (9)

  1. Ordinal distribution of mRS

    Ordinal distribution of mRS at 90 days.

    Measured: 90 days

  2. Favorable functional outcome

    Proportion of favorable functional outcome defined by an mRS score ≤ 2 point at 90 days

    Measured: 90 days

  3. Clinical response rate at 72 hours

    Clinical response rate at 72 hours defined by an improvement on NIHSS score ≥8 points compared with the initial deficit or a score ≤1.

    Measured: 72 hours

  4. The rate of improvement on reperfusion

    The rate of improvement on reperfusion at 24 hours (improved by 90% on Tmax>6s)

    Measured: 24 hours

  5. NIHSS change from baseline

    NIHSS change from baseline at 7 days

    Measured: 7 days

  6. Symptomatic intracranial hemorrhage

    Proportion of symptomatic intracranial hemorrhage (sICH) within 36 hours (as defined by The European Cooperative Acute Stroke Study III criteria [ECASSIII])

    Measured: 36 hours

  7. Mortality

    Rate of death from any cause within 90 days

    Measured: 90 days

  8. Systemic bleeding

    Rate of systemic bleeding at 90 days (as defined by The Global Utilisation of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries [GUSTO]: moderate and severe bleeding)

    Measured: 90 days

  9. Adverse events ( AEs ) / serious adverse events ( SAEs )

    Rate of adverse events ( AEs ) / serious adverse events ( SAEs ) within 90 days

    Measured: 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 posted2 Dec 2021
  2. Study start19 Jan 2022
  3. Primary completion29 Jan 2024
  4. Study completion9 Feb 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
Single blind
Who is masked
Outcomes assessor
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141305
Sponsor's protocol ID
MK02-2020-02
Acronym
TRACE III
Status last verified
Apr 2024
First submitted
19 Nov 2021
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hao M, Ma Y, Wang L, Jin A, Law ZK, Campbell BCV, Schwamm LH, Parsons MW, Fisher M, Xu Y, Xu A, Cao Z, Wang L, Wu S, Wang Y, Xiong Y. Neutrophil to Lymphocyte Ratio and Neurological Outcome in Ischemic Stroke at 4.5 to 24 Hours: A Post Hoc Analysis of TRACE-III Trial. Neurol Ther. 2026 Oct 16. doi: 10.1007/s40120-026-01060-5. Online ahead of print.

    PubMed 42886317

  • Wang H, Cao Z, Campbell BCV, Katsanos AH, Yin J, Fisher M, Wang Y, Xiong Y. Effects of Fibrinogen on Tenecteplase Treatment in Acute Ischaemic Stroke After 4.5 Hours of Symptom Onset: A Post Hoc Analysis of the TRACE-III Trial. Neurol Ther. 2026 Aug;15(4):1777-1788. doi: 10.1007/s40120-026-00958-4. Epub 2026 May 20.

    PubMed 42159994

  • Lu Z, Wang Z, Jin A, Che F, Wang L, Zhou L, Dai H, Liu X, Cao Z, Wang L, Hao M, Ye W, Xiong Y, Wang Y. Clinical benefit of tenecteplase despite failed recanalization in late-window ischemic stroke: a post hoc analysis of the TRACE-3 trial. BMC Med. 2026 Apr 16;24(1):328. doi: 10.1186/s12916-026-04877-x.

    PubMed 41992212

  • Xiong Y, Campbell BCV, Schwamm LH, Meng X, Jin A, Parsons MW, Fisher M, Jiang Y, Che F, Wang L, Zhou L, Dai H, Liu X, Pan Y, Duan C, Xu Y, Xu A, Zong L, Tan Z, Ye W, Wang H, Wang Z, Hao M, Cao Z, Wang L, Wu S, Li H, Li Z, Zhao X, Wang Y; TRACE-III Investigators. Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy. N Engl J Med. 2024 Jul 18;391(3):203-212. doi: 10.1056/NEJMoa2402980. Epub 2024 Jun 14.

    PubMed 38884324

  • Xiong Y, Campbell BCV, Fisher M, Schwamm LH, Parsons M, Li H, Pan Y, Meng X, Zhao X, Wang Y. Rationale and design of Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events III (TRACE III): a randomised, phase III, open-label, controlled trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):82-89. doi: 10.1136/svn-2023-002310.

    PubMed 37247876

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tenecteplase (0.25 mg/kg, Max 25 mg) and standard medical treatment in people with Ischemic Stroke, Acute, run by Beijing Tiantan 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 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 30 Apr 2024. 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 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?

Excellent functional outcome (time frame: 90 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 NCT05141305, which also lists 5 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 30 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in