NCT07536165

Brief Summary

The EXTEND-TNK Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous tenecteplase administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Dec 2029

First Submitted

Initial submission to the registry

March 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

March 30, 2026

Last Update Submit

April 10, 2026

Conditions

StrokeAcute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • The modified Rankin Scale score (mRS) 0-1

    The proportion of mRS score 0-1 or a return to baseline if the pre-stroke mRS score ≥2 at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death).

    90±14 days

Secondary Outcomes (8)

  • Level of disability

    90±14 days

  • The modified Rankin Scale score (mRS) 0-2

    90±14 days

  • The modified Rankin Scale score (mRS) 0-3

    90±14 days

  • Change in neurologic deficit (NIHSS score) at 24 hours

    24±12 hours

  • Change in neurologic deficit (NIHSS score) at 7 days or discharge

    7±1 days

  • +3 more secondary outcomes

Other Outcomes (5)

  • Symptomatic intracranial hemorrhage

    36 hours

  • Any intracranial hemorrhage

    36 hours

  • Serious adverse events during hospitalization

    7±1 days

  • +2 more other outcomes

Study Arms (1)

Extended time window intravenous tenecteplase

Drug: Tenecteplase

Interventions

TenecteplaseDRUG

Intravenous tenecteplase 0.25 mg/kg (maximum 25 mg) administered as a single IV bolus over 5-10 seconds. In this observational cohort, tenecteplase is the only thrombolytic agent included and there is no active comparator.

Extended time window intravenous tenecteplase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients (≥18 years) with acute ischemic stroke who receive intravenous tenecteplase more than 4.5 hours after last known well as part of standard clinical care.

You may qualify if:

  • \. Age ≥ 18 years;
  • \. Clinical diagnosed of acute ischemic stroke;
  • \. Time from last known well (LKW) to initiation of intravenous thrombolysis \> 4.5 hours (including wake-up stroke and unwitnessed stroke);
  • \. Received intravenous tenecteplase;
  • \. Provided written informed consent.

You may not qualify if:

  • \. Any condition judged by the investigator to make the participant unsuitable for study participation or follow-up (e.g., psychiatric disorders, cognitive impairment, or emotional disturbances).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Liuyang Jili Hospital

Guankou, Hunan, China

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Cerebrovascular 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

  • Yamei Tang

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

  • Yong He

    Liuyang Jili Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyi Bao

CONTACT

86-20-81332619baomy@mail2.sysu.edu.cn

Xinguang Yang

CONTACT

yangxinguang0926@163.com

Study Design

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

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The IPD will be available from the Principal Investigators (Prof. Yamei Tang and Prof. Yong He) upon reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after the trial completion.
Access Criteria
The IPD will be available from the Principal Investigators (Prof. Yamei Tang and Prof. Yong He) upon reasonable request.

Locations

CN(2)