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Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window

NCT06987305 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2025-12-31

No results posted yet for this study

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. 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.

Conditions

  • Stroke, Acute Ischemic

Interventions

DRUG

Intravenous rhTNK-tPA

Patients will received intravenous rhTNK-tPA

DRUG

Intravenous placebo

Patients will received intravenous placebo

PROCEDURE

Endovascular thrombectomy

Patients will received endovascular thrombectomy

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • China Shijiazhuang Pharmaceutical Company RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD

    collaborator UNKNOWN

  • Xinqiao Hospital of Chongqing

    lead OTHER

Principal Investigators

  • Qingwu Yang, MD · Department of Neurology, Xinqiao Hospital of the Army Medical University

  • Daojun Hong, MD · The First Affiliated Hospital of Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2027-10-31
Completion
2028-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06987305 on ClinicalTrials.gov