NCT06078995

Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tenecteplase	Thrombolysis wtih rhTNK-tPA
DRUG	Alteplase	Thrombolysis wtih rt-PA

Timeline

• Start date: 2023-04-02
• Primary completion: 2023-12-01
• Completion: 2024-05-01
• First posted: 2023-10-12
• Last updated: 2023-10-12

Locations

1 site across 1 country: China