Tests a clot-dissolving drug before thrombectomy in acute ischemic stroke
Tests a clot-dissolving drug given into a vein before thrombectomy in adults with stroke.
Plain-language title generated from the registry record
Registry title: Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
Key facts
- Where
- Jiujiang, Nanchang, Wuhan, and Xiangtan, ChinaSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an acute ischemic stroke caused by a blocked large brain artery, 4.5 to 24 hours after they were last known well, who are planned to have a clot-removal procedure (endovascular thrombectomy).
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with a blocked large brain artery seen on scans (CTA/MRA), starting 4.5-24 hours after last known well. Baseline NIHSS score of 5 or more. Brain scans must show salvageable brain tissue (specific CTP/MRP or MRI findings, or pc-ASPECTS score of 6 or more for back-of-brain strokes).
- Earlier treatment
- People who already received a clot-dissolving drug into a vein after this stroke cannot join. Before the stroke, people had little disability: mRS 2 or less if under 80, mRS 1 or less if 80 or older.
Main reasons for not taking part
- Bleeding in the brain seen on CT or MRI
- Already received intravenous thrombolytic after this stroke
- Pregnancy or breastfeeding
- Taking part in another drug trial at the same time
- Terminal illness with life expectancy under 6 months
Read by machine on 12 November 2026.
Where in China
- Jiujiang First People's HospitalJiujiang, ChinaContact: Tuanyuan Zheng, MDTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaContact: Daojun HongTaking people
- Wuhan NO.1 HospitalWuhan, ChinaContact: Wenhua Liu, MDTaking people
- Xiangtan Central HospitalXiangtan, ChinaContact: Guangxiong YuanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xinqiao Hospital of Chongqing
- Trial code
- NCT06987305
- Record updated
- 31 December 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: Already received intravenous thrombolytic after index stroke; Concurrent participation in other investigation drug clinical trials; Intracranial hemorrhage confirmed by CT/MRI; Pre-existing neurological/psychiatric disorders interfering with neurological assessment; Terminal illness with life expectancy <6 months; Pregnancy or lactation; Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel; Space-occupying intracranial tumors (except small meningiomas ≤3 cm); Intracranial aneurysm or arteriovenous malformation; Anticipated inability to complete follow-up assessments.