Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

August 26, 2026 updated by: First Affiliated Hospital of Guangxi Medical University

A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.

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

The study is an investigator-initiated, multicenter, prospective, observational, real-world registry designed to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. The study is anticipated to enroll at least 392 participants, with no less than 196 participants in the tenecteplase group.

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.
Observational

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.
392

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 Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • 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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will consecutively screen patients with acute ischemic stroke (AIS) who are over 80 years of age and arrive at the hospital within 4.5 hours of symptom onset.

Description

Inclusion Criteria:

  1. Age > 80 years;
  2. Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset;
  3. Informed consent signed by the patient or legally authorized representative.

Exclusion Criteria:

  1. Any contraindication to intravenous thrombolysis (excluding age);
  2. Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;
  3. Current participation in other interventional studies;
  4. The investigator deems the patient unsuitable for this study or the study might pose significant risk to the patient (e.g., due to psychiatric disorders, cognitive or emotional impairments that prevent understanding or adherence to study procedures and/or follow-up).

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Control group
Standard medical treatment
Other: Standard medical care
Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.
Tenecteplase group
Intravenous tenecteplase thrombolysis
Other: Standard medical care
Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.
Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.

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
Excellent outcome
Time Frame: 90 (±14) days
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
90 (±14) 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
Level of disability
Time Frame: 90 (±14) days
Ordinal shift analysis of the mRS with 5-6 merged at 90 days.
90 (±14) days
Functional independence
Time Frame: 90 (±14) days
The proportion of mRS score of 0-2 at 90 days.
90 (±14) days
Quality of life measured by EQ-5D-5L
Time Frame: 90 (±14) days
EQ-5D-5L scale score at 90 days.
90 (±14) days
Early neurological improvement
Time Frame: 24 (±12) hours
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours.
24 (±12) hours
Change in stroke severity
Time Frame: 7 (±1) days or at discharge
The change of NIHSS score from enrollment to 7 days or at discharge (whichever comes first).
7 (±1) days or at discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
All cause death within 90 days.
90 days
Symptomatic intracranial hemorrhage
Time Frame: 24 (±12) hours
Incidence of symptomatic intracranial hemorrhage within 36 hours from enrollment (Heidelberg criteria).
24 (±12) hours
Any intracranial hemorrhage
Time Frame: 24 (±12) hours
Incidence of any intracranial hemorrhage within 36 hours from enrollment (Heidelberg classification).
24 (±12) hours
Extracranial bleeding
Time Frame: 24 (±12) hours
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from enrollment.
24 (±12) hours

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.
First Affiliated Hospital of Guangxi Medical University

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: Yuan Wu, MD, PhD, First Affiliated Hospital of Guangxi Medical University

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.
March 22, 2026

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.
December 1, 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.
December 1, 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).
March 13, 2026

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.
March 13, 2026

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.
March 17, 2026

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.
August 31, 2026

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.
August 26, 2026

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, 2026

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.
  • 2025-K0668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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