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

Fudan University

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Drug: Tenecteplase; Drug: Alteplase

Study type: Observational

Funder types: Other

Identifiers

NCT06078995

20230726

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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%

Trial design

1,200 participants in 2 patient groups

Tenecteplase

Description:

acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase

Treatment:

Drug: Tenecteplase

alteplase

Description:

acute ischemic stroke patients who receive intravenous thrombolysis with alteplase

Treatment:

Drug: Alteplase