Tenecteplase REperfusion in Acute Ischemic sTroke Registry(TREAT)

NCT ID: NCT05724342

Last Updated: 2023-02-15

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

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-12-31

Brief Summary

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The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.

Detailed Description

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Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient.

This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.

Conditions

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Stroke, Ischemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rhTNK-tPA Thrombolysis

rhTNK-tPA Thrombolysis

Intervention Type DRUG

rhTNK-tPA Thrombolysis

Interventions

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rhTNK-tPA Thrombolysis

rhTNK-tPA Thrombolysis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years;
* Diagnosed as acute ischemic stroke;
* Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours);
* Thrombolysis with rhTNK-tPA and derivatives.

Exclusion Criteria

* Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months);
* Already participated in other interventional trials.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yunyun Xiong

Professor of Neurology and Stroke Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunyun Xiong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Yunyun Xiong

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunyun Xiong, MD, PhD

Role: CONTACT

00861059975213

Facility Contacts

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Yunyun Xiong

Role: primary

Other Identifiers

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KY2022-236-02

Identifier Type: -

Identifier Source: org_study_id

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