Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window. (TRACE-LATE)

December 8, 2025 updated by: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection (rhTNK-tPA, Mingfule) in Intravenous Thrombolysis for Acute Ischemic Stroke With Extended Time Window (4.5-24 Hours After Onset).

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study plans to enroll patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset (including wake-up strokes and strokes without witnesses). A centralized 1:1 randomization will be adopted, and eligible participants will be randomly assigned to two groups: the experimental group will receive rhTNK-tPA at a dose of 0.25 mg/kg, while the placebo group will receive rhTNK-tPA placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aims to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study initially planned to enroll 890 patients, who would be randomly assigned to the experimental group (rhTNK-tPA group) or the control group (placebo group) at a 1:1 ratio. After an unblinded sample size re-estimation during the interim analysis, the maximum sample size could be adjusted to 1,300 patients.

Key characteristics of the primary study population include: age ≥ 18 years; time from symptom onset to treatment ranging from 4.5 hours to 24 hours; occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; modified Rankin Scale (mRS) score ≤ 1 before symptom onset; baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6; and presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) combined with magnetic resonance perfusion (MRP) (ischemic core volume < 70 mL, mismatch ratio ≥ 1.8, and mismatch volume ≥ 15 mL). Patients with a known allergy to rhTNK-tPA and those with contraindications to thrombolysis were excluded.

The entire study duration is approximately 90 days, including the screening period, treatment period, and follow-up period. The primary study endpoint is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at the 90-day follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
890

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clinical Trials Information Group officer
  • Phone Number: 031169085587
  • Email: ctr-contact@cspc.cn

Study Locations

  • China
    • Henan
      • Puyang, Henan, China, 457001
        • Recruiting
        • Puyang Oilfield General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥ 18 years, regardless of gender;
  2. Time from symptom onset to treatment is 4.5 - 24 hours(Including the boundary values.), including patients with wake-up stroke or stroke without witnesses; the time of symptom onset is defined as the "last known normal time";
  3. Modified Rankin Scale (mRS) score ≤ 1 before stroke onset;
  4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
  5. Neuroimaging findings: occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA) confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) + magnetic resonance perfusion (MRP) (ischemic core volume < 70 mL, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 mL);
  6. Voluntary signing of the informed consent form by the participant or their legal guardian.

Exclusion Criteria:

  1. Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA);
  2. Patients with an expected life expectancy of less than 1 year;
  3. Patients with rapidly improving symptoms (which may indicate spontaneous recanalization), as determined by the investigator;
  4. Patients with a score of > 2 on Item 1a (Level of Consciousness) of the National Institutes of Health Stroke Scale (NIHSS), or those who had a seizure at stroke onset, or had hemiplegia after seizure, or had other neurological/psychiatric disorders that rendered them unable or unwilling to cooperate;
  5. Severe and persistent hypertension uncontrolled by medication ;
  6. Blood glucose < 2.8 mmol/L or > 22.2 mmol/L;
  7. Active internal bleeding with a high risk of hemorrhage;
  8. Any known coagulation disorder;
  9. Known platelet function defect or platelet count less than 100×10⁹/L;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Receive rhTNK-tPA administration at 0.25mg/kg, with the maximum dose not exceeding 25mg.
Drug: rhTNK-tPA
Each vial should be dissolved in 3mL of sterile water for injection to prepare a drug solution with a concentration of 5.33mg/mL. Calculate the total drug amount based on the participant's actual body weight, measure the required volume of the drug solution, and ensure the maximum dose does not exceed 25mg. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.
Placebo Comparator: Placebo Group
Receive placebo treatment, administration method and dosage same as rhTNK-tPA
Drug: Placebo
One vial is dissolved in 3mL of sterile water for injection. Calculate the total drug amount based on the participant's actual body weight, then measure the required volume of the drug solution. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of participants with a score of 0-1 on the modified Rankin Scale (mRS)
Time Frame: At Day90.
The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).
At Day90.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of symptomatic intracerebral hemorrhage within 36 hours after randomization
Time Frame: 36 Hours after Randomization
Defined by ECASS III: any intraparenchymal or intracranial hemorrhage associated with clinical deterioration, where the latter is defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale [NIHSS] score or death, with confirmation that the hemorrhage is the cause of neurological deterioration.
36 Hours after Randomization
Overall mortality rate at Day 90.
Time Frame: At Day90.
The proportion of randomized patients who died within 90 days
At Day90.
Incidence of significant systemic hemorrhage (moderate to severe per GUSTO classification) at Day 90.
Time Frame: At Day90.
For the Global Use of Strategies to Open Occluded Arteries (GUSTO) Classification, its core lies in categorizing bleeding into three grades-mild, moderate, and severe-based on the impact of bleeding on the patient's clinical status, treatment needs, and prognosis.
At Day90.
Proportion of adverse events (AEs)/serious adverse events (SAEs) at Day 90.
Time Frame: At Day90.
Adverse Event (AE) refers to any adverse medical event that occurs in a participant after administration of an investigational medicinal product. It may present as signs, symptoms, diseases, or abnormal laboratory findings, but it is not necessarily causally related to the investigational medicinal product. A Serious Adverse Event (SAE) refers to a special safety event among AEs that meets any of the following criteria: "resulting in death, life-threatening, requiring hospitalization/prolongation of existing hospitalization, causing permanent or severe disability/incapacity, leading to congenital anomalies/birth defects, or being another important medical event".
At Day90.
Modified Rankin Scale (mRS) score at Day 90 (shift analysis).
Time Frame: At Day90.
The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).
At Day90.
Title: Proportion of participants with mRS score of 0-2 at Day 90.
Time Frame: At Day90.
The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).
At Day90.
Proportion of participants with an NIHSS score of ≤1 or a reduction of ≥8 points from baseline within 72 hours after randomization.
Time Frame: 72 Hours after Randomization.
The National Institutes of Health Stroke Scale (NIHSS) is a globally accepted tool for assessing the severity of stroke. Primarily used in patients with acute stroke, it evaluates 11 neurological domains including consciousness, gaze, visual fields, facial palsy, limb motor function, sensation, and language. Scores ranging from 0 to 42 are assigned based on the degree of impairment, where a score of 0 indicates normal neurological function and a score of 42 indicates extremely severe impairment.
72 Hours after Randomization.
Change in NIHSS score from baseline at Day 7.
Time Frame: At Day7.
The National Institutes of Health Stroke Scale (NIHSS) is a globally accepted tool for assessing the severity of stroke. Primarily used in patients with acute stroke, it evaluates 11 neurological domains including consciousness, gaze, visual fields, facial palsy, limb motor function, sensation, and language. Scores ranging from 0 to 42 are assigned based on the degree of impairment, where a score of 0 indicates normal neurological function and a score of 42 indicates extremely severe impairment.
At Day7.
Proportion of participants with a Barthel Index (BI) score of ≥95 at Day 90.
Time Frame: At Day90.
The Barthel Index (BI) is a commonly used tool to assess the ability of self-care in daily life for patients with functional impairments (such as those with stroke or spinal cord injury). It mainly evaluates whether patients can independently perform 10 daily activities including eating, dressing, walking, and using the toilet, and assigns a score ranging from 0 to 100 based on their ability level: a score of 100 indicates complete self-care, and the lower the score, the higher the degree of dependence on others.
At Day90.
Rate of favorable reperfusion (90% improvement in Tmax >6s compared with prior status) within 24 hours after randomization.
Time Frame: 24 Hours after Randomization.
The rate of favorable reperfusion is defined as an improvement of 90% or more in the area with Tmax > 6s (compared with the previous status) on imaging examinations.
24 Hours after Randomization.
Growth of irreversible cerebral infarction volume before treatment and 24 hours after treatment.
Time Frame: 72 Hours after Treatment.
The volume of irreversible cerebral infarction refers to the brain tissue that has suffered irreversible damage after ischemia, and is also called the volume of core infarction.
72 Hours after Treatment.
Proportion of participants with favorable reperfusion (TICI 2b/3 or TICI 3) on angiography before endovascular treatment (limited to participants who received endovascular treatment).
Time Frame: Periprocedural
The Thrombolysis in Cerebral Infarction (TICI) Scale is a standard for assessing the degree of cerebral vascular recanalization in patients with acute ischemic stroke after endovascular treatment. It evaluates the blood flow recovery of the infarct-related artery via imaging examinations and is mainly categorized into Grades 0 to 3: Grade 0 represents no perfusion, Grade 1 mild perfusion, Grade 2 partial perfusion, and Grade 3 complete perfusion.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MK02-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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