Stroke, Acute IschemicPhase 3NCT06987305
Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
A Phase 3 study testing Intravenous rhTNK-tPA and Endovascular thrombectomy in people with Stroke, Acute Ischemic, run by Xinqiao Hospital of Chongqing at 4 sites in China.
Trial summary
This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Intravenous rhTNK-tPA and Endovascular thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 820 participants
- Where
- 4 sitesChina
- Study dates
- 21 Oct 2025to 29 Feb 2028
- 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
- Age ≥18 years;
- Acute ischemic stroke presenting within 4.5-24 hours of last known well;
- No significant pre-stroke functional disability: for age <80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
- Baseline NIHSS score ≥5;
- Imaging criteria of BOTH:
- Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm;
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- For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume <70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6.
- Plan to received endovascular thrombectomy;
- The patient or their legal representative provides written informed consent.
Who cannot join
- Intracranial hemorrhage confirmed by CT/MRI;
- Already received intravenous thrombolytic after index stroke.;
- Pregnancy or lactation;
- Concurrent participation in other investigation drug clinical trials;
- Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;
- Pre-existing neurological/psychiatric disorders interfering with neurological assessment;
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- Space-occupying intracranial tumors (except small meningiomas ≤3 cm);
- Intracranial aneurysm or arteriovenous malformation;
- Terminal illness with life expectancy <6 months;
- Anticipated inability to complete follow-up assessments.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Jiujiang First People's Hospital
Jiujiang, Jiangxi
Tuanyuan Zheng, MD, 13507925845, 85593542@qq.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Daojun Hong, 13879187691, hdj@ncu.edu.cn
- Recruiting
Wuhan No. 1 Hospital
Wuhan, Hubei, 430000
Wenhua Liu, MD, 8618871588816, leeoowh@yeah.net
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan, 421001
Guangxiong Yuan, 18973223018, yuanguangxiong74@163.com
About this study
Official title: Intravenous rhTNK-tPA Versus Placebo Before Endovascular Thrombectomy For Stroke Patient With Large Vessel Occlusion In The Extended Time Window: the BRIDGE-TNK EXTEND Randomized, Placebo-controlled, Double-blind Trial
This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhTNK-tPA enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhTNK-tPA increases the risk of symptomatic intracranial hemorrhage and mortality.
Participants will be randomized to receive either a single bolus of rhTNK-tPA (0.25 mg/kg, max 25 mg) or matching placebo administered intravenously over 5 seconds. Key assessments include repeat neuroimaging (CT/CTA or MRI/MRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.
Read the detailed description
This multicenter, phase III trial employs a randomized, double-blind, placebo-controlled design to investigate the therapeutic window extension for rhTNK-tPA in large vessel occlusion stroke. Eligible participants are adults with large vessel occlusion confirmed by vascular imaging (CTA/MRA), and salvageable brain tissue demonstrated by perfusion imaging (CTP/MRP) mismatch. Exclusion criteria include contraindications to thrombolysis, and large core infarction (>70 mL on CTP).
Patients will be randomized 1:1 to receive either weight-adjusted rhTNK-tPA (0.25 mg/kg) or placebo. All participants will undergo endovascular thrombectomy.
The primary outcome is functional independence (mRS 0-2) at 90 days. Secondary outcomes include substantial reperfusion at initial angiogram, first-pass reperfusion, final infarct volume on day 1.5 MRI/CT, etc. Safety outcomes include symptomatic intracranial hemorrhage per Heidelberg Bleeding Classification criteria within 36 hours, and 90-day mortality.
Safety monitoring includes independent adjudication of hemorrhagic events and all-cause mortality. A sample size of 820 participants provides 80% power to detect a 10% absolute difference in functional independence (α=0.05).
The trial incorporates centralized blinded outcome assessment and intention-to-treat analysis, with data oversight by an independent clinical events committee and data safety monitoring board.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Intravenous rhTNK-tPA, Intravenous placebo, Endovascular thrombectomy
- Keywords
- acute ischemic stroke, endovascular treatment, rhTNK-tPA
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous rhTNK-tPADrug
Also called Intravenous tenecteplase, Intravenous TNK
Patients will received intravenous rhTNK-tPA
Intravenous placeboDrug
Also called Intravenous placebo (a look-alike substance that contains no drug)
Patients will received intravenous placebo
Endovascular thrombectomyProcedure or surgery
Also called Endovascular treatment, Mechanical thrombectomy
Patients will received endovascular thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| rhTNK-tPA group | Experimental | Patients in this group will be treated with intravenous rhTNK-tPA and endovascular thrombectomy Receives: Drug: Intravenous rhTNK-tPA; Procedure: Endovascular thrombectomy |
| Placebo group | Placebo comparator | Patients in this group will be treated with intravenous placebo and endovascular thrombectomy Receives: Drug: Intravenous placebo; Procedure: Endovascular thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
functional independence
Measured: 90 days post-randomization
Secondary outcomes (9)
Substantial reperfusion (defined as an eTICI grade of 2b, 2c, or 3) at initial angiogram
The expanded Thrombolysis In Cerebral Infarction (eTICI) reperfusion grading system is a 6-point scale: 0 indicates no reperfusion noted; 1, reduction in thrombus without filling of distal arterial branches; 2a, reperfusion of <50% of the territory; 2b, a reperfusion of ≥50% of the territory; 2c, near-complete perfusion with distal slow flow or presence of small cortical emboli; and 3, complete reperfusion. Successful reperfusion at initial angiogram prior to thrombectomy was defined as an eTICI grade of 2b, 2c, or 3 on the first intracranial angiogram.
Measured: within 5 minutes at initial angiogram
Successful reperfusion (defined as an eTICI grade of 2b, 2c, or 3) at end-of-procedure angiography
The expanded Thrombolysis In Cerebral Infarction (eTICI) reperfusion grading system is a 6-point scale: 0 indicates no reperfusion noted; 1, reduction in thrombus without filling of distal arterial branches; 2a, reperfusion of <50% of the territory; 2b, a reperfusion of ≥50% of the territory; 2c, near-complete perfusion with distal slow flow or presence of small cortical emboli; and 3, complete reperfusion. This outcome will be evaluate at the end of procedure.
Measured: 15 minutes after initial angiogram
Modified first-pass reperfusion
defined as Expanded Treatment in Cerebral Infarction 2b, 2c, or 3 after the first thrombectomy pass
Measured: Perioperative (After artery puncture, but the start of procedure)
First-pass reperfusion
defined as Expanded Treatment in Cerebral Infarction 2c, or 3 after the first thrombectomy pass
Measured: Perioperative (After artery puncture, but the start of procedure)
Final infarct volume on day 1.5 MRI/CT
Infarct volume quantified via MRI/CT , with manual correction by certified radiologists.
Measured: 1.5 days post-randomization
Symptomatic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage (Heidelberg classification)
Measured: within 48 hours after endovascular treatment
Mortality within 90 days
evaluate death rate of the two treatment groups
Measured: 90 days post-randomization
Procedural-related complications
evaluate complications
Measured: within 90 days
Severe adverse events
evaluate any adverse events
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start21 Oct 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, Acute IschemicStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, China Shijiazhuang Pharmaceutical Company RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD
- Responsible party
- Principal investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
- Investigators
- Qingwu Yang, MD, Principal investigator, Department of Neurology, Xinqiao Hospital of the Army Medical UniversityDaojun Hong, MD, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987305
- Sponsor's protocol ID
- BRIDGE-TNK EXTEND
- Status last verified
- Dec 2025
- First submitted
- 7 May 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study data without patient information
Publications
Albers GW, Jumaa M, Purdon B, Zaidi SF, Streib C, Shuaib A, Sangha N, Kim M, Froehler MT, Schwartz NE, Clark WM, Kircher CE, Yang M, Massaro L, Lu XY, Rippon GA, Broderick JP, Butcher K, Lansberg MG, Liebeskind DS, Nouh A, Schwamm LH, Campbell BCV; TIMELESS Investigators. Tenecteplase for Stroke at 4.5 to 24 Hours with Perfusion-Imaging Selection. N Engl J Med. 2024 Feb 22;390(8):701-711. doi: 10.1056/NEJMoa2310392. Epub 2024 Feb 8.
PubMed 38329148Yogendrakumar V, Campbell BC, Churilov L, Garcia-Esperon C, Choi PM, Cordato DJ, Guha P, Sharma G, Chen C, McDonald A, Thijs V, Mamun A, Dos Santos A, Balabanski AH, Kleinig TJ, Butcher KS, Devlin MJ, O'Rourke F, Donnan GA, Davis SM, Levi CR, Ma H, Parsons MW. Extending the time window for tenecteplase by effective reperfusion of penumbral tissue in patients with large vessel occlusion: Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 trial. Int J Stroke. 2025 Mar;20(3):367-372. doi: 10.1177/17474930241308660. Epub 2024 Dec 31.
PubMed 39654273
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous rhTNK-tPA Versus Placebo Before Endovascular Thrombectomy For Stroke Patient With Large Vessel Occlusion In The Extended Time Window: the BRIDGE-TNK EXTEND Randomized, Placebo-controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT06987305
- Acronym / sponsor ID
- BRIDGE-TNK EXTEND
- Conditions
- Stroke, Acute Ischemic
- Keywords
- acute ischemic stroke, endovascular treatment, rhTNK-tPA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, China Shijiazhuang Pharmaceutical Company RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhTNK-tPA enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhTNK-tPA increases the risk of symptomatic intracranial hemorrhage and mortality.
Participants will be randomized to receive either a single bolus of rhTNK-tPA (0.25 mg/kg, max 25 mg) or matching placebo administered intravenously over 5 seconds. Key assessments include repeat neuroimaging (CT/CTA or MRI/MRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.
Detailed description
This multicenter, phase III trial employs a randomized, double-blind, placebo-controlled design to investigate the therapeutic window extension for rhTNK-tPA in large vessel occlusion stroke. Eligible participants are adults with large vessel occlusion confirmed by vascular imaging (CTA/MRA), and salvageable brain tissue demonstrated by perfusion imaging (CTP/MRP) mismatch. Exclusion criteria include contraindications to thrombolysis, and large core infarction (>70 mL on CTP).
Patients will be randomized 1:1 to receive either weight-adjusted rhTNK-tPA (0.25 mg/kg) or placebo. All participants will undergo endovascular thrombectomy.
The primary outcome is functional independence (mRS 0-2) at 90 days. Secondary outcomes include substantial reperfusion at initial angiogram, first-pass reperfusion, final infarct volume on day 1.5 MRI/CT, etc. Safety outcomes include symptomatic intracranial hemorrhage per Heidelberg Bleeding Classification criteria within 36 hours, and 90-day mortality.
Safety monitoring includes independent adjudication of hemorrhagic events and all-cause mortality. A sample size of 820 participants provides 80% power to detect a 10% absolute difference in functional independence (α=0.05).
The trial incorporates centralized blinded outcome assessment and intention-to-treat analysis, with data oversight by an independent clinical events committee and data safety monitoring board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTNK-tPA group | Experimental | Drug: Intravenous rhTNK-tPA, Procedure: Endovascular thrombectomyPatients in this group will be treated with intravenous rhTNK-tPA and endovascular thrombectomy |
| Placebo group | Placebo comparator | Drug: Intravenous placebo, Procedure: Endovascular thrombectomyPatients in this group will be treated with intravenous placebo and endovascular thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years;
- Acute ischemic stroke presenting within 4.5-24 hours of last known well;
- No significant pre-stroke functional disability: for age <80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
- Baseline NIHSS score ≥5;
- Imaging criteria of BOTH:
Key exclusion criteria (10 listed)
- Intracranial hemorrhage confirmed by CT/MRI;
- Already received intravenous thrombolytic after index stroke.;
- Pregnancy or lactation;
- Concurrent participation in other investigation drug clinical trials;
- Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous rhTNK-tPAAlso: Intravenous tenecteplase, Intravenous TNKPatients will received intravenous rhTNK-tPA | Drug | rhTNK-tPA group |
| Intravenous placeboAlso: Intravenous placebo (a look-alike substance that contains no drug)Patients will received intravenous placebo | Drug | Placebo group |
| Endovascular thrombectomyAlso: Endovascular treatment, Mechanical thrombectomyPatients will received endovascular thrombectomy | Procedure or surgery | Placebo group, rhTNK-tPA group |
Primary outcome
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
Time frame: 90 days post-randomization
functional independence
9 secondary outcomes
Substantial reperfusion (defined as an eTICI grade of 2b, 2c, or 3) at initial angiogram
Time frame: within 5 minutes at initial angiogram
Successful reperfusion (defined as an eTICI grade of 2b, 2c, or 3) at end-of-procedure angiography
Time frame: 15 minutes after initial angiogram
Modified first-pass reperfusion
Time frame: Perioperative (After artery puncture, but the start of procedure)
First-pass reperfusion
Time frame: Perioperative (After artery puncture, but the start of procedure)
Final infarct volume on day 1.5 MRI/CT
Time frame: 1.5 days post-randomization
Symptomatic intracranial hemorrhage within 48 hours
Time frame: within 48 hours after endovascular treatment
Mortality within 90 days
Time frame: 90 days post-randomization
Procedural-related complications
Time frame: within 90 days
Severe adverse events
Time frame: within 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 38329148Albers GW, Jumaa M, Purdon B, Zaidi SF, Streib C, Shuaib A, Sangha N, Kim M, Froehler MT, Schwartz NE, Clark WM, Kircher CE, Yang M, Massaro L, Lu XY, Rippon GA, Broderick JP, Butcher K, Lansberg MG, Liebeskind DS, Nouh A, Schwamm LH, Campbell BCV; TIMELESS Investigators. Tenecteplase for Stroke at 4.5 to 24 Hours with Perfusion-Imaging Selection. N Engl J Med. 2024 Feb 22;390(8):701-711. doi: 10.1056/NEJMoa2310392. Epub 2024 Feb 8.
- Background: PubMed 39654273Yogendrakumar V, Campbell BC, Churilov L, Garcia-Esperon C, Choi PM, Cordato DJ, Guha P, Sharma G, Chen C, McDonald A, Thijs V, Mamun A, Dos Santos A, Balabanski AH, Kleinig TJ, Butcher KS, Devlin MJ, O'Rourke F, Donnan GA, Davis SM, Levi CR, Ma H, Parsons MW. Extending the time window for tenecteplase by effective reperfusion of penumbral tissue in patients with large vessel occlusion: Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 trial. Int J Stroke. 2025 Mar;20(3):367-372. doi: 10.1177/17474930241308660. Epub 2024 Dec 31.
- Individual participant dataSharing planned: Yes. study data without patient information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qingwu Yang, MD principal investigator
Department of Neurology, Xinqiao Hospital of the Army Medical University
Daojun Hong, MD principal investigator
The First Affiliated Hospital of Nanchang University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous rhTNK-tPA and Endovascular thrombectomy in people with Stroke, Acute Ischemic, run by Xinqiao Hospital of Chongqing at 4 sites 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 Zhongming Qiu, MD (13236599269, qiuzhongmingdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days (time frame: 90 days post-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 NCT06987305, which also lists 2 linked publications.
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 31 Dec 2025.