Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China (TTT-AIS CHINA)

October 9, 2023 updated by: Qiang Dong, Huashan Hospital

Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA.

This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.

Study Type

Observational

Enrollment (Estimated)

1200

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 Locations

  • China
      • Shanghai, China
        • Recruiting
        • Xin Chen
        • Contact:
          • Xin Cheng

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • variables with a missing rate > 40%

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
Intervention / Treatment
Tenecteplase
acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase
Drug: Tenecteplase
Thrombolysis wtih rhTNK-tPA
Other Names:
  • rhTNK-tPA
alteplase
acute ischemic stroke patients who receive intravenous thrombolysis with alteplase
Drug: Alteplase
Thrombolysis wtih rt-PA
Other Names:
  • rt-PA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with symptomatic intracranial hemorrhage within 36 hours
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
90 days mRS 0-1
Time Frame: at 90±7 days
modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.
at 90±7 days
90 days mRS shift
Time Frame: at 90±7 days
a shift analysis of the distribution of modified Rankin Scale score which measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.
at 90±7 days
discharge mRS
Time Frame: at discharge (up to 30 days)
modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.
at discharge (up to 30 days)
24 hours NIHSS score
Time Frame: at 24 hours after receiving thrombolysis
The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.
at 24 hours after receiving thrombolysis
discharge NIHSS score
Time Frame: at discharge (up to 30 days)
The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.
at discharge (up to 30 days)
Rate of patients with any systematic bleeding
Time Frame: during hospital stay (up to 30 days)
Rate of patients with any systematic bleeding requiring blood infusion during hospital stay reflecting short term safety outcome
during hospital stay (up to 30 days)
Rate of patients with 90 days mortality
Time Frame: at 90±7 days
Rate of patients with all-cause mortality within 90 days reflecting safety outcome
at 90±7 days
Rate of patients with any intracranial hemorrhage
Time Frame: during hospital stay (up to 30 days)
Rate of patients with any intracranial hemorrhage without significant neurological deterioration on the brain imaging reflecting short term safety outcome
during hospital stay (up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Collaborators

Shanghai 10th People's Hospital
Shanghai Fifth People's Hospital
Shanghai Deji Hospital
Nanshi Hospital of Nanyang
Ruijin Hospital Luwan Branch
Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum
The First Affiliated Hospital of Ningbo University
Jilin Liuhe Hospital
Shenyang Fifth People's hospital
Shanghai East Hospita
Shanghai Pudong Gongli hospital
Shanghai Neuromedical Center
Shanghai Fourth People's Hospital
Shanghai Pudong People's Hospital
Shanghai Putuo Liqun Hospital
Shenyang Fushun general hospital of mining bureau
Yantai Affliated Hosiptal of Binzhou Medical University
Shanghai Ninth People's Hospital Huangpu Branch

Investigators

  • Principal Investigator: Qiang Dong, Huashan Hospital

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)

April 2, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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