IV tenecteplase given before clot removal for large-vessel ischemic stroke in the 4.5–24 hour window

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 3 trial randomizes adults with confirmed large-vessel occlusion and salvageable brain tissue to a single weight-adjusted IV bolus of rhTNK-tPA or matching placebo prior to endovascular thrombectomy. Key imaging selection uses CTA/MRA plus perfusion mismatch (or DWI-FLAIR criteria) to identify patients with core <70 mL and salvageable tissue; posterior circulation cases require pc-ASPECTS ≥6. Primary outcome is functional independence (mRS 0–2) at 90 days, with coprimary and secondary mechanistic endpoints including pre-thrombectomy reperfusion, first-pass reperfusion, and early infarct volume; safety outcomes focus on symptomatic intracranial hemorrhage and 90-day mortality. The trial uses centralized blinded outcome assessment, independent event adjudication and a data safety monitoring board and plans ~820 participants for adequate power.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years;
2. Acute ischemic stroke presenting within 4.5-24 hours of last known well;
3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
4. Baseline NIHSS score ≥5;
5. Imaging criteria of BOTH:

   1. 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;
   2. 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.
6. Plan to received endovascular thrombectomy;
7. The patient or their legal representative provides written informed consent.

Exclusion Criteria:

1. Intracranial hemorrhage confirmed by CT/MRI;
2. Already received intravenous thrombolytic after index stroke.;
3. Pregnancy or lactation;
4. Concurrent participation in other investigation drug clinical trials;
5. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;
6. Pre-existing neurological/psychiatric disorders interfering with neurological assessment;
7. Space-occupying intracranial tumors (except small meningiomas ≤3 cm);
8. Intracranial aneurysm or arteriovenous malformation;
9. Terminal illness with life expectancy \<6 months;
10. Anticipated inability to complete follow-up assessments.

Where it's running

• Wuhan No. 1 Hospital
  Wuhan, Hubei, China Recruiting
• Xiangtan Central Hospital
  Xiangtan, Hunan, China Recruiting
• Jiujiang First People's Hospital
  Jiujiang, Jiangxi, China Recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Principal investigator: Qingwu Yang, MD — Department of Neurology, Xinqiao Hospital of the Army Medical University
• Study coordinator: Zhongming Qiu, MD
• Email: qiuzhongmingdoctor@163.com
• Phone: 13236599269

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.