NCT06987305RecruitingPhase 3
Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
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
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 820 (estimated)
- First submitted
- 7 May 2025
- Start date
- Oct 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Diseases
- Stroke
- NCT number
- NCT06987305
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 820
- From Oct 2025 to the primary completion date, Oct 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Already received intravenous thrombolytic after index stroke.;
- Concurrent participation in other investigation drug clinical trials;
Other illness
- Intracranial hemorrhage confirmed by CT/MRI;
- Pre-existing neurological/psychiatric disorders interfering with neurological assessment;
- Terminal illness with life expectancy \<6 months;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiujiang First People's Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Wuhan NO.1 Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Xiangtan Central Hospital Coordinator of this site? Confirm its status | Xiangtan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.