Acute Ischemic StrokePhase 3TREASURENCT07253181
Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours
A Phase 3 study testing Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial summary
This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion, Transportation of Patients
- What is being tested?
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 2 sitesChina
- Study dates
- 6 Jan 2026to 30 Mar 2028
- Phase
- Phase 3
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 of 18 years or older;
- AIS symptom onset to treatment initiation within 4.5 to 24 hours, stroke onset is defined as the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke);
- Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery (ICA), M1 or proximal M2 vessels;
- Functionally independent (mRS 0-2) prior to stroke onset;
- Baseline National Institute of Health Stroke Scale (NIHSS) of 6-25;
- Intended to transfer to ECCs for EVT (patient transfer), or intended to transfer a neurointerventionalist from the ECC for EVT (physician transfer);
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- Written informed consent from patients or legally authorized representatives;
- Neuroimaging: large vessel occlusion (ICA, M1, proximal M2) by MRA or CTA AND the target mismatch profile on computed tomography perfusion (CTP) or magnetic resonance perfusion (MRP), defined as an ischemic core volume <70mL, mismatch volume ≥15mL and mismatch ratio ≥1.8;
- Alternative neuroimaging (if CTP or MRP is technically inadequate or unavailable):
- An Alberta Stroke Program Early CT Score (ASPECTS) score ≥7 on NCCT or MRI scan;
Who cannot join
- Known hypersensitivity or allergy to any ingredients of Tenecteplase;
- Intended to receive IVT as standard-of-care therapy;
- Rapidly improving symptoms with NIHSS score <6 before randomization;
- Any contra-indication for IVT except for the time criterion;
- Known hereditary or acquired hemorrhagic diathesis;
- Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, INR >1.7 or prothrombin time >15s; if use of any direct oral anticoagulant within the last 48 hours; if on any full dose heparin/heparinoid within the last 24 hours;
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- Ischemic stroke or myocardial infarction in previous 3 months
- Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months;
- Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);
- Other serious, advanced or terminal illness with life expectancy less than 6 months;
- Baseline blood glucose <50mg/dl or >400mg/dl;
- Contraindication to imaging with contrast agents;
- Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA or MRA (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion);
- Extensive early ischemic change on non-contrast CT or MRI-DWI estimated to be >1/3 MCA territory, or significant hypodensity outside the Tmax>6s perfusion lesion that invalidates mismatch criteria (if patient is enrolled based on CT perfusion criteria); any CT or MRI findings indicative of a high risk of sICH related to potential intravenous tenecteplase treatment in the judgement of the investigator;
- Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation;
- Current participation in another investigational drug or device study;
- Suspected endocarditis;
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Gaoting Ma, MD, +8683198082, demo_doctor@163.com
- Recruiting
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, 261031
Guosheng Han, MS, +8683198082, hanguosheng001@126.com
About this study
Official title: Tenecteplase Before inteRhospital Transfer for Endovascular Treatment in pAtientS With acUte Anterior ciRculation Large vEssel Occlusion at 4.5 to 24 Hours
This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT).
- Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care
- Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.
- Being tested
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
- Keywords
- interhospital transfer, acute ischemic stroke, anterior circulation large vessel 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.
Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)Drug
Tenecteplase at a nECC before EVT transfer
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase before transfer | Experimental | Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg. Tenecteplase is for IV administration only. A single bolus dose should be administered over 5 seconds based on patient weight. Transport to ECCs or transfer physician for EVT should be initiated as early as possible after administration according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023. Receives: Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) |
| Standard of care | No intervention | Patients will receive standard treatment and be directly transferred to ECCs or transfer physician for EVT according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of disability (ordinal mRS score)
the ordinal score on the modified Rankin scale; The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death).
Measured: at 90 (±7) days
Secondary outcomes (8)
Excellent outcome
mRS of 0-1 vs. 2-6
Measured: at 90 (±7) days
Functional independence
mRS of 0-2 vs. 3-6
Measured: at 90 (±7) days
Ambulatory and self-care capable
mRS of 0-3 vs. 4-6
Measured: at 90 (±7) days
Health-related quality of life
Score on the EuroQol Group 5-Dimension 5-Level [EQ-5D-5L] questionnaire; range, -0.39 to 1, with higher scores indicating better quality of life)
Measured: at 90 (±7) days
Incidence of arterial recanalization
Arterial imaging performed at ECC arrival, either CTA/MRA/or first run of DSA
Measured: Day 1
First pass reperfusion
First pass reperfusion refers to achievement of recanalization by single pass, near-complete to complete recanalization of the occlusion site (eTICI 2c or 3) and no need for rescue treatment
Measured: intraoperative, immediately after the first pass
Successful reperfusion
successful reperfusion is defined as extended Treatment In Cerebral Ischemia (eTICI) grades of 2b, 2c or 3
Measured: immediately after the endovascular intervention
Recanalization
Measured: at 24 (±12) hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start6 Jan 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Model description
- This is a phase Ⅲ, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim (China) Investment Co., Ltd, Jeffrey Saver, Maarten Lansberg, Thanh N. Nguyen, Pierre Seners, Jens Fiehler, Raul G. Nogueira
- Responsible party
- Sponsor
- Investigators
- Junwei Hao, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253181
- Sponsor's protocol ID
- [2025]372-001
- Acronym
- TREASURE
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to Chinese laws and regulations, the IPD will not be shared.