Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China

NCT ID: NCT06078995

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-02

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tenecteplase

acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase

Tenecteplase

Intervention Type DRUG

Thrombolysis wtih rhTNK-tPA

alteplase

acute ischemic stroke patients who receive intravenous thrombolysis with alteplase

Alteplase

Intervention Type DRUG

Thrombolysis wtih rt-PA

Interventions

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Tenecteplase

Thrombolysis wtih rhTNK-tPA

Intervention Type DRUG

Alteplase

Thrombolysis wtih rt-PA

Intervention Type DRUG

Other Intervention Names

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rhTNK-tPA rt-PA

Eligibility Criteria

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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%
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum

UNKNOWN

Sponsor Role collaborator

Nanshi Hospital of Nanyang

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role collaborator

Jilin Liuhe Hospital

UNKNOWN

Sponsor Role collaborator

Shenyang Fifth People's hospital

UNKNOWN

Sponsor Role collaborator

Shanghai East Hospita

UNKNOWN

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai Fifth People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Pudong Gongli hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Neuromedical Center

UNKNOWN

Sponsor Role collaborator

Shanghai Fourth People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Pudong People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Putuo District Center Hospital

OTHER

Sponsor Role collaborator

Shenyang Fushun general hospital of mining bureau

UNKNOWN

Sponsor Role collaborator

Yantai Affliated Hosiptal of Binzhou Medical University

UNKNOWN

Sponsor Role collaborator

Shanghai Ninth People's Hospital Huangpu Branch

UNKNOWN

Sponsor Role collaborator

Shanghai Deji Hospital

UNKNOWN

Sponsor Role collaborator

Ruijin Hospital Luwan Branch

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiang Dong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Dong

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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Xin Chen

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiang Dong, M.D. Ph.D.

Role: CONTACT

86-021-52887142

Facility Contacts

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Xin Cheng

Role: primary

Other Identifiers

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20230726

Identifier Type: -

Identifier Source: org_study_id

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