A Phase 3 interventional study of Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) in Acute Ischemic Stroke and Large Vessel Occlusion, sponsored by Fujian Medical University Union Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Fujian Medical University Union Hospital · Phase 3, Interventional, and Treatment
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.
2,679 studies on the registry are indexed under Ischemic Stroke; 959 are open to participants now.
This study's planned enrollment of 1,266 is above the median of 120 across 1,818 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Fujian Medical University Union Hospital is the lead sponsor of 107 studies on the registry; 78 are open to participants now.
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Participants must meet all of the following criteria:
Exclusion Criteria:
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.
Imaging Exclusion Criteria:
Participants 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.
Drug: Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)
Participants 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.
Drug page: Tenecteplase
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.
Also known as: rhTNK-tPA
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.
Time frame: Day 90 ± 7 days after randomization
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.
Time frame: Day 90 ± 7 days after randomization
Excellent Functional Outcome at 90 Days
Proportion of participants with a modified Rankin Scale score of 0 to 1 at 90 days after randomization.
Time frame: Day 90 ± 7 days after randomization
Favorable Functional Outcome at 90 Days
Proportion of participants with a modified Rankin Scale score of 0 to 3 at 90 days after randomization.
Time frame: Day 90 ± 7 days after randomization
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.
Time frame: Within 24 hours after randomization (at the first vascular imaging assessment upon arrival at the receiving stroke center).
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.
Time frame: Within 48 hours after randomization
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.
Time frame: 72 ± 12 hours after randomization
EQ-5D-5L Score at 90 Days
EQ-5D-5L assessment at 90 days after randomization, performed by an assessor blinded to treatment allocation.
Time frame: Day 90 ± 7 days after randomization
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.
Time frame: Day 90 ± 7 days after randomization
Symptomatic Intracranial Hemorrhage Within 48 Hours
Proportion of participants with symptomatic intracranial hemorrhage within 48 hours after randomization, adjudicated according to the Heidelberg Bleeding Classification.
Time frame: Within 48 hours after randomization
All-Cause Mortality Within 90 Days
Proportion of participants who die from any cause within 90 days after randomization.
Time frame: From randomization through day 90
Any Intracranial Hemorrhage Within 48 Hours
Proportion of participants with any intracranial hemorrhage detected on brain imaging within 48 hours after randomization, classified according to the Heidelberg Bleeding Classification.
Time frame: Within 48 hours after randomization
Serious Adverse Events Within 90 Days
Proportion of participants who experience at least one serious adverse event within 90 days after randomization.
Time frame: From randomization through day 90
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tenecteplase
Fujian Medical University Union Hospital →