NCT07475936

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

Conditions

Acute Ischemic StrokeTenecteplase

Outcome Measures

Primary Outcomes (1)

  • Excellent outcome

    The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days

    90 (±14) days

Secondary Outcomes (5)

  • Level of disability

    90 (±14) days

  • Functional independence

    90 (±14) days

  • Early neurological improvement

    24 (±12) hours

  • Change in stroke severity

    7 (±1) days or at discharge

  • Quality of life measured by EQ-5D-5L

    90 (±14) days

Other Outcomes (4)

  • Symptomatic intracranial hemorrhage

    24 (±12) hours

  • Any intracranial hemorrhage

    24 (±12) hours

  • Extracranial bleeding

    24 (±12) hours

  • +1 more other outcomes

Study Arms (2)

Control group

Standard medical treatment

Other: Standard medical care

Tenecteplase group

Intravenous tenecteplase thrombolysis

Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)Other: Standard medical care

Interventions

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)DRUG

Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.

Tenecteplase group
Standard medical careOTHER

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.

Control groupTenecteplase group

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Any contraindication to intravenous thrombolysis (excluding age);
  • Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;
  • Current participation in other interventional studies;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen ActivatorSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Yuan Wu, MD, PhD

    First Affiliated Hospital of Guangxi Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Pan, MD, PhD

CONTACT

86-156 2648 3251dongpan012@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

CN(1)