Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke (BRIDGE-TNK)

March 30, 2025 updated by: Zhongming Qiu, Xinqiao Hospital of Chongqing

Intravenous rhTNK-tPA Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Randomized Controlled Trial

The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.

Study Overview

Status

Status

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

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

The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.

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 (Actual)

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.
550

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 2
  • 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.

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • Xinqiao Hospital of Army Medical University
    • Henan
      • Jiaozuo, Henan, China
        • The Second Hospital of Jiaozuo
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Wuhan No. 1 Hospital
    • Hunan
      • Hengyang, Hunan, China
        • The First Affiliated Hospital, Hengyang Medical School, University of South China
      • Xiangtan, Hunan, China, 525000
        • Xiangtan Central Hospital
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • The 904th Hospital of CPLA

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older;
  2. Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well;
  3. No significant prestroke functional disability: for age <80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
  4. MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
  5. EVT is planned by clinical care team;
  6. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

  1. Intracranial hemorrhage on baseline CT or MR
  2. Contraindication to intravenous thrombolytics
  3. Already received intravenous thrombolytic after index stroke
  4. Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission
  5. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys
  6. Current participation in another investigational drug clinical trial
  7. Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel
  8. Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments
  9. Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation)
  10. Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma)
  11. Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography
  12. Any terminal disease with a life expectancy less than half a year
  13. Unlikely to be available for follow-up at 90 days.

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: Single

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: Conbined treatment group
intravenous tenecteplase bridging with endovascular treatment
Drug: rhTNK-tPA
intravenous thrombolysis with rhTNK-tPA followed by endovascular treatment
Other Names:
  • TNKase
  • TNK-tPA
Other: Endovascular treatment
endovascular treatment
Other Names:
  • interventional therapy
  • intra-arterial treatment
Active Comparator: Endovascular treatment alone group
endovascular treatment alone
Other: Endovascular treatment
endovascular treatment
Other Names:
  • interventional therapy
  • intra-arterial treatment

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
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
Time Frame: 90 days
functional independence
90 days

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
Mortality within 90 days
Time Frame: 90 days
evaluate death rate of the two treatment groups
90 days
modified Rankin scale score
Time Frame: 90 days
disability level
90 days
Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)
Time Frame: 90 days
excellent outcome
90 days
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
Time Frame: 90 days
ambulatory or bodily needs-capable or better
90 days
Substantial reperfusion at initial angiogram
Time Frame: within 5 minutes at initial angiogram
evaluate effect of tenecteplase on reperfusion
within 5 minutes at initial angiogram
Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Time Frame: 90 days
Health-related quality of life
90 days
Successful reperfusion at end-of-procedure angiography
Time Frame: 15 minutes after initial angiogram
evaluate vascular patency after thrombectomy
15 minutes after initial angiogram
National Institutes of Health Stroke Scale (NIHSS) score
Time Frame: 5 to 7 days or discharge
Neurological status
5 to 7 days or discharge
First-pass reperfusion
Time Frame: After artery puncture, but before thrombectomy
defined as Expanded Treatment in Cerebral Infarction ≥2c after the first thrombectomy pass
After artery puncture, but before thrombectomy
Modified first-pass reperfusion
Time Frame: After artery puncture, but before thrombectomy
defined as Expanded Treatment in Cerebral Infarction ≥2b after the first thrombectomy pass
After artery puncture, but before thrombectomy
Any radiologic intracranial hemorrhage within 48 hours
Time Frame: within 48 hours after endovascular treatment
evaluate intracranial hemorrhage
within 48 hours after endovascular treatment
Symptomatic intracranial hemorrhage within 48 hours
Time Frame: within 48 hours after endovascular treatment
evaluate intracranial hemorrhage (Heidelberg classification)
within 48 hours after endovascular treatment
Procedural-related complications
Time Frame: within 90 days
evaluate complications
within 90 days
Severe adverse events
Time Frame: within 90 days
evaluate any adverse events
within 90 days

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.
Xinqiao Hospital of Chongqing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qingwu Yang, MD, Neurology, Xinqiao Hospital of the Army Medical University
  • Principal Investigator: Wenjie Zi, MD, Neurology, Xinqiao Hospital of the Army Medical University
  • Principal Investigator: Raul G Nogueira, MD, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA
  • Principal Investigator: Jeffrey L Saver, MD, Neurology, University of California, Los Angeles, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
May 9, 2022

Primary Completion (Actual)

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.
December 16, 2024

Study Completion (Actual)

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.
February 7, 2025

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).
January 26, 2021

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.
January 31, 2021

First Posted (Actual)

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.
February 2, 2021

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.
April 3, 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.
March 30, 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.
March 1, 2025

More Information

Terms related to this study

Keywords

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.
  • BRIDGE-TNK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study data without patient information

IPD Sharing Time Frame

Related papers published 3 months later, the IPD will be shared.

IPD Sharing Access Criteria

yangqwmlys@163.com ziwenjie1981@163.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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