Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

Capital Medical University

Status: Enrolling

Conditions: Stroke, Ischemic

Treatments: Drug: rhTNK-tPA Thrombolysis

Study type: Observational

Funder types: Other

Identifiers

NCT05724342

KY2022-236-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,600 participants in 1 patient group

rhTNK-tPA Thrombolysis

Treatment:

Drug: rhTNK-tPA Thrombolysis