A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke (TRANSIT)

October 26, 2024 updated by: Jialing Wu, Tianjin Huanhu Hospital

Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke : a Multicenter, Prospective, Observational, Real-world Study（TRANSIT）

Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Ischemic strokes account for 60-70% of all strokes worldwide and are severely debilitating, drawing considerable attention due to their high prevalence.The majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studies.The aim of this study is to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in clinical practice. This study aimed to establish a foundation for refining intravenous thrombolytic therapy tailored to various patient profiles and to guide clinicians in selecting the most suitable thrombolytic treatment options.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

TRANSIT is a prospective, multicenter, open-label real world study.The purpose of this study was to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in practical clinical applications. To provide the basis for optimizing the intravenous thrombolysis program for different types of patients, and to provide a reference for clinicians to choose the appropriate thrombolytic therapy program.

6000 individuals who met the indications for intravenous thrombolysis and signed informed consent were included.The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, or alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families. Assessments were conducted at baseline, as well as at 24, 36, and 72 hours post-thrombolysis. Follow-up evaluations were performed on day 7 (or prior to discharge) and day 90.The primary efficacy endpoint was the proportion of excellent functional outcomes at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The primary safety outcome was the proportion of sICH within 36 h (as defined by The European Cooperative Acute Stroke Study III criteria).The economic endpoint included the total costs of the first hospitalization and the days at home within 90±7 days.

Study Type

Observational

Enrollment (Estimated)

6000

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 Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300350
        • Recruiting
        • Tianjin Huanhu 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ischemic stroke within 4.5 hours last known well (including wake-up stroke and no witness stroke )were included in the study.

Description

Inclusion Criteria:

- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal.

3. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.

Exclusion Criteria:

  • 1. Any absolute contraindication to thrombolysis in the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TNK group
The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg.
Other: Tenecteplase
The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, based on their clinical condition and the preferences expressed by the patients and their families.
rtPA group
The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg.
Other: Alteplase
The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS
Time Frame: 90±7 days after enrollment
The primary efficacy endpoint is the proportion of excellent functional outcome at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The modified Rankin Scale is commonly used to measure neurological recovery after stroke on a scale of 0-6, with higher scores associated with worse outcomes .
90±7 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS score
Time Frame: 72h after treatment
Incidence of neurological improvement at 72h after treatment (proportion of subjects with NIHSS score ≤1 point or 8 points or more lower than baseline )
72h after treatment
proportion of sICH
Time Frame: 36h after treatment
The safety outcome is the proportion of sICH within 36 hours (as defined by The European Cooperative Acute Stroke Study III criteria）
36h after treatment
rate of death
Time Frame: 90 days after enrollment
Secondary safety end points related to Rate of death from any cause within and Rate of systemic bleeding within 90 days.
90 days after enrollment
mRS
Time Frame: 90±7 days after enrollment
Improvement of mRS Scores at 90±7 days (shift analysis)
90±7 days after enrollment
mRS
Time Frame: 90±7 days after enrollment
The proportion of favourable functional outcome at 90±7 days (mRS 0-2)
90±7 days after enrollment
NIHSS score
Time Frame: 7±1 days after enrollment
Incidence of Neurological deterioration at 7±1 days (NIHSS score increased by ≥2 points and cerebral hemorrhage was excluded)
7±1 days after enrollment
stroke recurrence
Time Frame: 90±7 days after enrollment
Incidence of stroke recurrence and other vascular events at 90±7 days.
90±7 days after enrollment

Collaborators and Investigators

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

Sponsor

Tianjin Huanhu Hospital

Investigators

  • Principal Investigator: Jialing Wu, MD,PhD, Tianjin Huanhu Hospital

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 (Estimated)

October 26, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJL-2024-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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