Stroke IschemicPhase 3NCT07073469
Tenecteplase in ReperfUsion Therapy for Posterior Circulation Stroke With Extended Time Window: the TRUST Trial
A Phase 3 study testing Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment in people with Stroke Ischemic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 TNK compared to standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Ischemic
- What is being tested?
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 ≥ 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
- 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
- Contraindications for tenecteplase:
- Allergy to tenecteplase
- 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
Show all 18Show fewer
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 TNK 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.
Our previous EXPECTs trial have proved the effectiveness and safety of intravenous alteplase in patients with posterior circulation stroke within 4.5-24 hours of onset. However, the effectiveness of tenecteplase (TNK) has not been studied in this subgroup of 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 TNK in the Chinese population.
- Conditions
- Stroke Ischemic
- Being tested
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Standard medical treatment
- 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 (TNK) (0.25 mg/kg, to maximum of 25mg)Drug
Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
Standard medical treatmentOther
Standard medical treatment according to local guidelines
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tenecteplase with standard therapy | Experimental | Patients will receive standard dose intravenous tenecteplase (0.25 mg per kilogram, with a maximum dose of 25 mg) Receives: Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) |
| Standard therapy | Active comparator | Standard therapy Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (8)
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
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
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
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
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
Parenchymal hematoma (PH) (%) within 36 hours after randomization
PH as defined by the European Cooperative Acute Stroke Study [ECASS] criteria
Measured: within 36 hours
Any intracerebral hemorrhage (ICH) within 36 hours after randomization
Measured: within 36 hours
Mortality (%) within 90 days
Mortality refers to rate of death from any cause
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke IschemicStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 330 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Lou, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073469
- Sponsor's protocol ID
- TRUST
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase in ReperfUsion Therapy for Posterior Circulation Stroke With Extended Time Window: the TRUST Trial
- ClinicalTrials.gov ID
- NCT07073469
- Acronym / sponsor ID
- TRUST
- Conditions
- Stroke Ischemic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 TNK compared to standard care.
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.
Our previous EXPECTs trial have proved the effectiveness and safety of intravenous alteplase in patients with posterior circulation stroke within 4.5-24 hours of onset. However, the effectiveness of tenecteplase (TNK) has not been studied in this subgroup of 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 TNK in the Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Tenecteplase with standard therapy | Experimental | Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)Patients will receive standard dose intravenous tenecteplase (0.25 mg per kilogram, with a maximum dose of 25 mg) |
| Standard therapy | Active comparator | Other: Standard medical treatmentStandard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 ≥ 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
- 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
Key exclusion criteria (18 listed)
- Contraindications for tenecteplase:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) | Drug | Experimental: Tenecteplase with standard therapy |
| Standard medical treatmentStandard medical treatment according to local guidelines | Other | Standard therapy |
Primary outcome
Ordinal distribution of modified Rankin Scale (mRS) score at 90 ± 7 days
Time frame: 90 ± 7 days
mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
8 secondary outcomes
Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days
Time frame: 90 ± 7 days
Independent recovery assessed by ratio of modified Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days
Time frame: 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
Time frame: 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
Time frame: 7 days
Symptomatic intracerebral hemorrhage (sICH) within 36 hours after randomization
Time frame: within 36 hours
Parenchymal hematoma (PH) (%) within 36 hours after randomization
Time frame: within 36 hours
Any intracerebral hemorrhage (ICH) within 36 hours after randomization
Time frame: within 36 hours
Mortality (%) within 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment in people with Stroke Ischemic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 18 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: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou (8615925622176, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ordinal distribution of modified Rankin Scale (mRS) score 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?
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 15 Aug 2025.