A Phase 3 interventional study of rhTNK-tPA (0.25mg/kg) and Reteplase 10 Units (U) plus a second dose of reteplase 10 U in Acute Ischemic Stroke, Large Vessel Occlusion and Anterior Circulation Brain Infarction, sponsored by Yongjun Wang. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Yongjun Wang · Phase 3, Interventional, and Treatment
Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain.
The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT.
Participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thrombolysis with tenecteplase or reteplase before mechanical thrombectomy compared with direct mechanical thrombectomy. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization. If superiority of bridging thrombolysis is demonstrated, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.
Mechanical thrombectomy (MT) has become the standard of care for eligible patients with acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Randomized controlled trials and individual patient-level meta-analyses have demonstrated substantial improvements in functional outcomes with MT compared with medical management alone.
However, the optimal strategy for intravenous thrombolysis before mechanical thrombectomy remains uncertain. Previous randomized trials evaluating bridging thrombolysis have primarily investigated alteplase, and the additional clinical benefit of intravenous thrombolysis before MT compared with direct MT has not been conclusively established.
Tenecteplase and reteplase are two thrombolytic agents that may provide potential alternatives to alteplase in the bridging thrombolysis setting. Tenecteplase, administered at a dose of 0.25 mg/kg, has demonstrated promising efficacy and safety profiles in patients with acute ischemic stroke, with increasing evidence supporting its use as a bridging thrombolytic agent before MT. Reteplase, administered as two intravenous bolus doses of 18 mg, has also shown potential as an alternative thrombolytic agent and requires further evaluation in patients undergoing MT.
The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design). The trial will enroll adults with acute ischemic stroke who present within 4.5 hours of symptom onset and have imaging-confirmed anterior circulation large vessel occlusion. Participants must meet predefined eligibility criteria for intravenous thrombolysis and mechanical thrombectomy. Eligible participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization.
The primary objective of the trial is to determine whether bridging thrombolysis with tenecteplase or reteplase, analyzed as a combined treatment strategy, is superior to direct mechanical thrombectomy alone in achieving functional independence at 90 days. If superiority is established, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.
The planned sample size is 1,440 participants, with a maximum total sample size of 1,800 participants if sample size re-estimation is performed according to pre-specified criteria. An interim analysis is planned after approximately 60% of the originally planned sample size has been enrolled. The interim analysis will include a non-binding futility assessment and may include sample size re-estimation.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 1,440 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Yongjun Wang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) administered as a single intravenous bolus at a dose of 0.25 mg/kg (maximum dose 25 mg) within 4.5 hours of symptom onset and prior to mechanical thrombectomy, followed by standard endovascular treatment.
Drug: rhTNK-tPA (0.25mg/kg)
Recombinant human plasminogen activator derivative (rPA) administered as two intravenous bolus doses of 18 mg each, given over approximately 2 minutes per bolus and separated by a 30-minute interval. The first dose should be administered within 4.5 hours of symptom onset before mechanical thrombectomy. To avoid delays in reperfusion therapy, groin puncture and endovascular treatment may be initiated after administration of the first bolus without waiting for the second dose. The second bolus should be administered according to the prespecified dosing regimen unless contraindicated.
Drug: Reteplase 10 Units (U) plus a second dose of reteplase 10 U
Mechanical thrombectomy performed according to standard practice without administration of intravenous thrombolytic agents.
Procedure: No thrombolysis (thrombectomy alone)
Drug page: Tenecteplase
Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) administered as a single intravenous bolus at a dose of 0.25 mg/kg (maximum dose 25 mg) within 4.5 hours of symptom onset prior to mechanical thrombectomy.
Also known as: Tenecteplase
Drug page: Reteplase
Two intravenous bolus injections of 18 mg each, administered within 4.5 hours of onset over approximately 2 minutes per bolus, separated by a 30-minute interval prior to thrombectomy. To avoid delays in reperfusion therapy, groin puncture and MT procedures may be initiated after administration of the first 18 mg bolus, without waiting for completion of the second bolus. Unless contraindicated, the second rPA bolus should be administered according to the scheduled dosing regimen irrespective of EVT status.
Also known as: rPA
Patients will undergo mechanical thrombectomy according to standard practice, without administration of intravenous thrombolytic agents.
Functional Independence
Proportion of participants achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.
Time frame: From randomization to 90 days after randomization (±7 days), with outcome assessment performed by blinded assessors.
Excellent functional outcome
Proportion of participants achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.
Time frame: From randomization to 90 days after randomization (±7 days), with outcome assessment performed by blinded assessors.
Favorable functional outcome
Proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-3 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.
Time frame: 90 days after randomization (±7 days), assessed by blinded outcome assessors.
Early neurological improvement
Proportion of participants achieving major early neurological recovery at 24 hours after randomization, defined as a reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of ≥8 points or an NIHSS score of 0-1. The NIHSS ranges from 0 (no neurological deficit) to 42 (maximum neurological impairment), with higher scores indicating greater neurological impairment.
Time frame: 22-36 hours after randomization
Neurological improvement
Proportion of participants achieving neurological improvement at day 7 or discharge, whichever occurs first, defined as a reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of ≥8 points or an NIHSS score of 0-1. The NIHSS ranges from 0 (no neurological deficit) to 42 (maximum neurological impairment), with higher scores indicating greater neurological impairment.
Time frame: Day 7 after randomization or discharge, whichever occurs first (±1 day)
Pre-procedural recanalization
Proportion of participants with successful reperfusion on initial diagnostic angiography before any endovascular device manipulation, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2b, 2c, or 3. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion.
Time frame: During the endovascular procedure, before endovascular device manipulation
Near-complete reperfusion post endovascular treatment
Proportion of participants achieving near-complete reperfusion at the end of the endovascular procedure, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2c or 3. The eTICI grade of 2c or 3 indicates near-complete to complete reperfusion, with residual perfusion defects limited to slow flow in a few distal cortical vessels or small distal cortical emboli.
Time frame: At the end of the endovascular procedure (immediately after completion of the procedure)
Successful reperfusion post endovascular Treatment
Proportion of participants achieving successful reperfusion at the end of the endovascular procedure, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2b, 2c, or 3. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion. An eTICI grade of 2b, 2c, or 3 indicates reperfusion of at least 50% of the affected vascular territory.
Time frame: At the end of the endovascular procedure (immediately after completion of the procedure)
First-pass reperfusion
Proportion of participants achieving near-complete reperfusion after the first thrombectomy pass, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2c or 3. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion. An eTICI grade of 2c or 3 represents near-complete or complete reperfusion, respectively.
Time frame: Immediately after the first thrombectomy pass during the endovascular procedure
Modified first-pass reperfusion
Proportion of participants achieving a modified first-pass effect, defined as successful reperfusion with an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2b, 2c, or 3 after a single thrombectomy pass. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion.
Time frame: Immediately after the first thrombectomy pass during the endovascular procedure
Health Related Quality of Life
Health-related quality of life assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire at 90 days after randomization. The EQ-5D-5L is a standardized instrument used to describe and value health status across five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Time frame: 90 days after randomization (±7 days)
Barthel index≥95
Proportion of participants achieving a Barthel Index (BI) score of ≥95 at 90 days after randomization. The BI is a standardized scale used to assess activities of daily living and functional independence, ranging from 0 (complete dependence) to 100 (complete independence), with higher scores indicating greater functional ability.
Time frame: 90 days after randomization (±7 days)
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage (sICH) based on modified Heidelberg Bleeding Classification intracranial hemorrhage on follow-up imaging associated with neurological deterioration (≥4-point increase in total NIHSS or ≥2-point increase in one NIHSS item), major medical intervention such as intubation, hemicraniectomy, external ventricular drainage, or death.
Time frame: Up to 36 hours from randomization
Parenchymal Hematoma Type 2
Proportion of participants with parenchymal hematoma type 2 (PH2), defined as a blood clot involving more than 30% of the infarcted area with substantial mass effect, according to the Heidelberg Bleeding Classification.
Time frame: Up to 36 hours from randomization
Procedure-related complications
Proportion of participants experiencing endovascular procedure-related complications, including vessel perforation, vessel dissection, distal embolization to a new territory (ENT), clinically significant vasospasm, access site complications, and contrast extravasation unrelated to vessel perforation.
Time frame: From the start of the endovascular procedure to 7 days after randomization
Major Bleeding
Proportion of participants experiencing major bleeding within 90 days after randomization, defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, including fatal bleeding, bleeding in a critical organ (e.g., intracranial, intraspinal, intraocular, or retroperitoneal bleeding), a fall in hemoglobin level of ≥2 g/dL, or transfusion of ≥2 units of red blood cells.
Time frame: 90 days after randomization (±7 days)
Clinically relevant non-major bleeding
Proportion of participants experiencing clinically relevant non-major bleeding (CRNMB) within 90 days after randomization, defined as bleeding that does not meet criteria for major bleeding but requires medical intervention, unscheduled medical evaluation, hospitalization, or close monitoring.
Time frame: 90 days after randomization (±7 days)
All-cause mortality at 7 days
Proportion of participants who died from any cause within 7 days after randomization.
Time frame: Within 7 days after randomization
All-cause mortality at 90 days
Proportion of participants who died from any cause within 90 days after randomization.
Time frame: 90 days after randomization (±7 days)
Adverse events, serious adverse events, and suspected unexpected serious adverse reactions
Proportion of participants experiencing adverse events (AEs), serious adverse events (SAEs), or suspected unexpected serious adverse reactions (SUSARs) within 90 days after randomization.
Time frame: 90 days after randomization (±7 days)
Started Oct 2026 (actual). Primary completion is estimated for Mar 2029, 28 months after the start.
Of 143 non-industry phase 3 interventional studies under Ischemic Stroke, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 28 months is below that.
Counting every sponsor, half of 165 studies reached it within 30 months; a quarter within 19 and three quarters within 52.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 drugs tested here: Tenecteplase · Reteplase
Yongjun Wang