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Acute Ischemic StrokePhase 3Union-transferNCT07912970

Tenecteplase Bridging Thrombolysis Prior to Inter-hospital Transfer for Endovascular Therapy in Anterior Circulation Large Vessel Occlusion Stroke Within 4.5-24 Hours

A Phase 3 study testing Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Fujian Medical University Union Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This multicenter, randomized clinical trial will assess whether intravenous tenecteplase given before interhospital transfer improves outcomes compared with direct transfer without tenecteplase. 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
What is being tested?
Tenecteplase (rhTNK-tPA) (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
1,266 participants
Where
1 siteChina
Study dates
1 Apr 2027to 1 Mar 2030
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

  • Participants must meet all of the following criteria:
  • Age ≥18 years.
  • Time from stroke onset or last known well to randomization >4.5 hours and ≤24 hours.
  • Diagnosis of acute ischemic stroke with a baseline NIHSS score ≥6 before randomization.
  • Pretreatment CTA or MRA demonstrating occlusion of the M1 segment or the proximal M2 segment of the dominant division of the MCA, identified as the target vessel responsible for the presenting stroke.
  • A small infarct volume demonstrated by either of the following imaging criteria: Alberta Stroke Program Early CT Score (ASPECTS) ≥7 for MCA-M1 occlusion or ASPECTS 9-10 for MCA-M2 occlusion; or CTP or MRP demonstrating salvageable ischemic brain tissue and meeting all of the following criteria: (1) Infarct-core volume, defined as relative cerebral blood flow (rCBF) <30% or an apparent diffusion coefficient (ADC) <620 × 10-⁶ mm²/s on diffusion-weighted imaging (DWI), ≤70 mL; (2) Ischemic mismatch volume, defined as the volume with Tmax >6 seconds minus the infarct-core volume, ≥15 mL; (3) Ratio of ischemic-tissue volume to infarct-core volume ≥1.8.
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  • Prestroke mRS score of 0-2.
  • Planned interhospital transfer to a thrombectomy-capable stroke center for EVT.
  • The estimated interval from randomization to arterial puncture at the EVT center is ≥90 minutes.
  • Written informed consent provided by the participant or the participant's legally authorized representative.

Who cannot join

  • Participants meeting any of the following criteria will be excluded:
  • Any contraindication to intravenous thrombolysis, including: 1) Significant head trauma or stroke within the previous 3 months; 2) Symptoms suggestive of subarachnoid hemorrhage; 3) Arterial puncture at a noncompressible site within the previous 7 days; 4) History of intracranial hemorrhage; 5) Intracranial neoplasm, arteriovenous malformation, or aneurysm; 6) Recent intracranial or intraspinal surgery; 7) Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg; 8) Active internal bleeding; 9) Acute bleeding tendency, including but not limited to: Platelet count <100,000/mm³ (100 × 10⁹/L); Heparin administration within the previous 48 hours with an activated partial thromboplastin time above the upper limit of normal; Current oral anticoagulant therapy; International normalized ratio >1.7 or prothrombin time >15 seconds; or Current use of a direct thrombin inhibitor or direct factor Xa inhibitor with elevated relevant sensitive laboratory parameters, such as activated partial thromboplastin time, international normalized ratio, platelet count, ecarin clotting time, thrombin time, or an appropriate factor Xa activity assay; 10) Blood glucose <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.20 mmol/L).
  • Note: In participants without a history of or clinical suspicion for a coagulation abnormality, enrollment need not be delayed while awaiting coagulation-test results.
  • Pregnancy, breastfeeding, or a positive pregnancy test.
  • Known hypersensitivity to tenecteplase, heparin, contrast media, or anesthetic agents, or any other definite contraindication to EVT.
  • Severe arterial tortuosity or another condition that makes EVT technically infeasible.
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  • A pre-existing neurologic or psychiatric disorder that may interfere with neurologic assessment.
  • Multiple-vessel occlusion, such as simultaneous bilateral anterior-circulation large-vessel occlusion or simultaneous anterior- and posterior-circulation large-vessel occlusion.
  • Terminal illness associated with a life expectancy of <6 months.
  • Anticipated inability to complete the required follow-up.
  • Current participation in another study that may affect the assessment of outcomes in this trial.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for the trial.
  • Imaging Exclusion Criteria:
  • A large established infarction on CT, defined as hypodensity involving more than one-third of a cerebral hemisphere.
  • Intracranial hemorrhage confirmed by CT or MRI, including intraparenchymal, intraventricular, subarachnoid, subdural, or epidural hemorrhage.
  • A brain tumor with mass effect on imaging, except for a small meningioma.
  • Intracranial aneurysm or arteriovenous malformation. Suspected aortic dissection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenhuo Chen contact

0591-86218022

docterwwenhuo@126.com

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Wenhuo Chen, 0591-86218022, doctorwwenhuo@126.com

Other trials in China

About this study

Official title: Efficacy and Safety of Tenecteplase Thrombolysis as Bridging Thrombolysis Prior to Inter-hospital Transfer for Endovascular Therapy in Anterior Circulation Large Vessel Occlusion Stroke Within 4.5-24 Hours: A Multicenter Randomized Controlled Clinical Trial

This multicenter, randomized clinical trial will assess whether intravenous tenecteplase given before interhospital transfer improves outcomes compared with direct transfer without tenecteplase. Eligible participants are adults with acute ischemic stroke caused by occlusion of the M1 segment or proximal dominant M2 segment of the middle cerebral artery, more than 4.5 hours and no more than 24 hours after symptom onset or the last known well time.

Participants will be assigned in a 1:1 ratio to receive tenecteplase before transfer or to undergo direct transfer without study-related intravenous thrombolysis. At the receiving stroke center, both groups will be evaluated for endovascular therapy and treated when clinically indicated. The primary outcome is the proportion of participants with a modified Rankin Scale score of 0-2 at 90 days after randomization. The study will also assess neurological improvement, vessel reopening, intracranial hemorrhage, and other clinical outcomes.

Being tested
Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)
Keywords
Tenecteplase, Bridging Thrombolysis, Endovascular Therapy, Inter-hospital Transfer
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 (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)Drug

    Also called rhTNK-tPA

    Tenecteplase will be administered at a dose of 0.25 mg/kg, with a maximum dose of 25 mg, as a single intravenous bolus over 5-10 seconds before interhospital transfer.

Study groups in NCT07912970
Study groupRoleWhat they receive
Tenecteplase GroupExperimentalParticipants will receive intravenous tenecteplase at a dose of 0.25 mg/kg, with a maximum dose of 25 mg, as a single bolus before interhospital transfer. Interhospital transfer to a thrombectomy-capable stroke center will be initiated immediately after tenecteplase administration. At the receiving center, participants will be evaluated for endovascular therapy and treated according to current clinical guidelines.
Receives: Drug: Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)
Direct-Transfer GroupNo interventionParticipants are transferred directly to the receiving stroke center without study-assigned intravenous tenecteplase before transfer. At the receiving center, they are evaluated for endovascular therapy, which is performed if clinically indicated. Participants receive standard medical care according to clinical needs.

What is being measured

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

  1. Functional Independence at 90 Days

    Proportion of participants with functional independence at 90 days after randomization, defined as a modified Rankin Scale score of 0 to 2. The modified Rankin Scale ranges from 0 to 6, with lower scores indicating less disability.

    Measured: Day 90 ± 7 days after randomization

Secondary outcomes (8)

  1. Distribution of Modified Rankin Scale Scores at 90 Days

    Distribution of modified Rankin Scale scores at 90 days after randomization. The modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability.

    Measured: Day 90 ± 7 days after randomization

  2. Excellent Functional Outcome at 90 Days

    Proportion of participants with a modified Rankin Scale score of 0 to 1 at 90 days after randomization.

    Measured: Day 90 ± 7 days after randomization

  3. Favorable Functional Outcome at 90 Days

    Proportion of participants with a modified Rankin Scale score of 0 to 3 at 90 days after randomization.

    Measured: Day 90 ± 7 days after randomization

  4. Early Recanalization of the Target Vessel at the Receiving Stroke Center

    Proportion of participants with recanalization of the initially occluded target vessel on the first vascular imaging assessment at the receiving stroke center, assessed by CTA, MRA, or the first DSA.

    Measured: Within 24 hours after randomization (at the first vascular imaging assessment upon arrival at the receiving stroke center).

  5. Successful Recanalization of the Target Vessel Within 48 Hours

    Proportion of participants with recanalization of the initially occluded target vessel on CTA or MRA within 48 hours after randomization.

    Measured: Within 48 hours after randomization

  6. Early Neurological Improvement

    Proportion of participants with a decrease in the National Institutes of Health Stroke Scale (NIHSS) score of at least 8 points from baseline, or an NIHSS score of 0 to 1, at the 72-hour assessment.

    Measured: 72 ± 12 hours after randomization

  7. EQ-5D-5L Score at 90 Days

    EQ-5D-5L assessment at 90 days after randomization, performed by an assessor blinded to treatment allocation.

    Measured: Day 90 ± 7 days after randomization

  8. Barthel Index at 90 Days

    Barthel Index score at 90 days after randomization, assessed by an assessor blinded to treatment allocation. Scores range from 0 to 100, with higher scores indicating greater independence in activities of daily living.

    Measured: Day 90 ± 7 days after randomization

Timeline

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

  1. First posted3 Nov 2026
  2. Study start1 Apr 2027 (estimated)
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Mar 2030 (estimated)

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
Model description
Two-arm, parallel-group, randomized controlled trial comparing tenecteplase before interhospital transfer with direct transfer for endovascular therapy.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07912970
Sponsor's protocol ID
Fujian Province Union Hospital
Acronym
Union-transfer
Status last verified
Oct 2026
First submitted
21 Oct 2026
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Fujian Medical University Union 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 10 inclusion and 17 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 3 Nov 2026. 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?

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 Wenhuo Chen (0591-86218022, docterwwenhuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Independence at 90 Days (time frame: Day 90 ± 7 days after randomization). 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 NCT07912970.

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 3 Nov 2026.

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