Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

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: Not yet recruiting
• Conditions: Acute Ischemic Stroke; Tenecteplase
• Intervention / Treatment: Other: Standard medical care; Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

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: Observational
• Enrollment (Estimated): 392

Contacts and Locations

• Study Contact: Name: Dong Pan, MD, PhD; Phone Number: 86-156 2648 3251; Email: dongpan012@hotmail.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Dong Pan, MD, PhD; Phone Number: 86-156 2648 3251; Email: dongpan012@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Excellent outcome	The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days	90 (±14) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of disability	Ordinal shift analysis of the mRS with 5-6 merged at 90 days.	90 (±14) days
Functional independence	The proportion of mRS score of 0-2 at 90 days.	90 (±14) days
Quality of life measured by EQ-5D-5L	EQ-5D-5L scale score at 90 days.	90 (±14) days
Early neurological improvement	The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours.	24 (±12) hours
Change in stroke severity	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

Outcome Measure	Measure Description	Time Frame
Mortality	All cause death within 90 days.	90 days
Symptomatic intracranial hemorrhage	Incidence of symptomatic intracranial hemorrhage within 36 hours from enrollment (Heidelberg criteria).	24 (±12) hours
Any intracranial hemorrhage	Incidence of any intracranial hemorrhage within 36 hours from enrollment (Heidelberg classification).	24 (±12) hours
Extracranial bleeding	Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from enrollment.	24 (±12) hours

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University
• Investigators: Principal Investigator: Yuan Wu, MD, PhD, First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Amino Acids, Peptides, and Proteins; Proteins; Hydrolases; Enzymes; Enzymes and Coenzymes; Blood Proteins; Endopeptidases; Peptide Hydrolases; Serine Endopeptidases; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Tissue Plasminogen Activator; Tenecteplase
• Other Study ID 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