Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours (TREASURE)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke; Large Vessel Occlusion; Transportation of Patients
• Intervention / Treatment: Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

• Study Type: Interventional
• Enrollment (Estimated): 572
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gaoting Ma, MD; Phone Number: +8683198082; Email: demo_doctor@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Gaoting Ma, MD; Phone Number: +8683198082; Email: demo_doctor@163.com
  • Shandong
    • Weifang, Shandong, China, 261031
      • Recruiting
      • Affiliated Hospital of Shandong Second Medical University
      • Contact: Guosheng Han, MS; Phone Number: +8683198082; Email: hanguosheng001@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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), MCA (M1 or 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);
• Written informed consent from patients or legally authorized representatives;
• Neuroimaging: ICA or M1, M2 occlusion 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):

The presence of a diffusion-weighted imaging (DWI)-fluid-attenuated inversion recovery (FLAIR) mismatch pattern (i.e., acute ischemic lesion visible on DWI but no marked parenchymal hyperintensity visible on FLAIR) OR an Alberta Stroke Program Early CT Score (ASPECTS) score ≥7 on NCCT or MRI scan;

Exclusion Criteria:

• 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;
• 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);
• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tenecteplase before transfer; 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.	Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg); Tenecteplase at a nECC before EVT transfer
No Intervention: Standard of care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 90 (±7) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of arterial recanalization	Arterial imaging performed at ECC arrival, either CTA/MRA/or first run of DSA	Day 1
Recanalization		at 24 (±12) hours
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	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	immediately after the endovascular intervention
Excellent outcome	mRS of 0-1 vs. 2-6	at 90 (±7) days
Functional independence	mRS of 0-2 vs. 3-6	at 90 (±7) days
Ambulatory and self-care capable	mRS of 0-3 vs. 4-6	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)	at 90 (±7) days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic intracranial hemorrhage (sICH)	using Heidelberg criteria	within 36 hours
Parenchymal hematoma type 2 (PH2)		within 36 hours
All-cause mortality		up to 90 (±7) days

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Boehringer Ingelheim (China) Investment Co., Ltd; Jeffrey Saver; Maarten Lansberg; Thanh N. Nguyen; Pierre Seners; Jens Fiehler; Raul G. Nogueira
• Investigators: Principal Investigator: Junwei Hao, MD, PhD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: acute ischemic stroke; interhospital transfer; anterior circulation large vessel occlusion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Amino Acids, Peptides, and Proteins; Proteins; Hydrolases; Enzymes; Enzymes and Coenzymes; Blood Proteins; Endopeptidases; Peptide Hydrolases; Serine Endopeptidases; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Tissue Plasminogen Activator; Tenecteplase
• Other Study ID Numbers: [2025]372-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to Chinese laws and regulations, the IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No