NCT06078995

Brief Summary

The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

April 2, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 3, 2023

Last Update Submit

October 9, 2023

Conditions

Ischemic Stroke

Keywords

intravenous thrombolysisTenecteplase

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with symptomatic intracranial hemorrhage within 36 hours

    Clinical deterioration or neurological decline causing an increase in NIHSS score of ≥4 points due to intracranial hemorrhage confirmed by brain imaging

    36 hours

Secondary Outcomes (8)

  • 90 days mRS 0-1

    at 90±7 days

  • 90 days mRS shift

    at 90±7 days

  • discharge mRS

    at discharge (up to 30 days)

  • 24 hours NIHSS score

    at 24 hours after receiving thrombolysis

  • discharge NIHSS score

    at discharge (up to 30 days)

  • +3 more secondary outcomes

Study Arms (2)

Tenecteplase

acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase

Drug: Tenecteplase

alteplase

acute ischemic stroke patients who receive intravenous thrombolysis with alteplase

Drug: Alteplase

Interventions

TenecteplaseDRUG

Thrombolysis wtih rhTNK-tPA

Also known as: rhTNK-tPA
Tenecteplase
AlteplaseDRUG

Thrombolysis wtih rt-PA

Also known as: rt-PA
alteplase

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

acute ischemic stroke patients treated with rhTNK-tPA or rt-PA in China.

You may qualify if:

  • all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset.

You may not qualify if:

  • variables with a missing rate \> 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xin Chen

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

TenecteplaseTissue Plasminogen Activator

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Qiang Dong

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Dong, M.D. Ph.D.

CONTACT

86-021-52887142qiang_dong163@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 12, 2023

Study Start

April 2, 2023

Primary Completion

December 1, 2023

Study Completion

May 1, 2024

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

CN(1)