Health TrialsbyHealthPanel

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

ConditionStroke, Acute Ischemic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinqiao Hospital of Chongqing

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Intracranial hemorrhage confirmed by CT/MRI;

Already received intravenous thrombolytic after index stroke.;

Pregnancy or lactation;

Concurrent participation in other investigation drug clinical trials;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous rhTNK-tPA

    Drug

    Patients will received intravenous rhTNK-tPA

  • Intravenous placebo

    Drug

    Patients will received intravenous placebo

  • Endovascular thrombectomy

    Procedure/Surgery

    Patients will received endovascular thrombectomy

Treatment groups

820 Participants
are divided into 2 treatment groups
Group A: rhTNK-tPA groupExperimental treatment 2 interventions
Group B: Placebo groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients functionally independent (mRS score 0 to 2) at 90 days

functional independence

Time frame
90 days post-randomization

Secondary outcomes

1

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.

Time frame
within 5 minutes at initial angiogram
2

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.

Time frame
15 minutes after initial angiogram
3

Modified first-pass reperfusion

defined as Expanded Treatment in Cerebral Infarction 2b, 2c, or 3 after the first thrombectomy pass

Time frame
Perioperative (After artery puncture, but the start of procedure)
4

First-pass reperfusion

defined as Expanded Treatment in Cerebral Infarction 2c, or 3 after the first thrombectomy pass

Time frame
Perioperative (After artery puncture, but the start of procedure)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

The First Affiliated Hospital of Nanchang University

Collaborator

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

Collaborator

Source ClinicalTrials.gov
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