Clinical trial NCT06078995: Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
Official title: Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: intravenous thrombolysis
Tenecteplase
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum
name: Nanshi Hospital of Nanyang
name: First Affiliated Hospital of Ningbo University
name: Jilin Liuhe Hospital
name: Shenyang Fifth People's hospital
name: Shanghai East Hospita
name: Shanghai 10th People's Hospital
name: Shanghai Fifth People's Hospital
name: Shanghai Pudong Gongli hospital
name: Shanghai Neuromedical Center
name: Shanghai Fourth People's Hospital
name: Shanghai Pudong People's Hospital
name: Shanghai Putuo District Center Hospital
name: Shenyang Fushun general hospital of mining bureau
name: Yantai Affliated Hosiptal of Binzhou Medical University
name: Shanghai Ninth People's Hospital Huangpu Branch
name: Shanghai Deji Hospital
name: Ruijin Hospital Luwan Branch
First posted: 2023-10-12
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute ischemic stroke patients treated with rhTNK-tPA or rt-PA in China.

Brief 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.

Eligibility criteria: 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%

Primary outcomes:
measure: Rate of patients with symptomatic intracranial hemorrhage within 36 hours
timeFrame: 36 hours
Secondary outcomes:
measure: 90 days mRS 0-1
timeFrame: at 90±7 days
measure: 90 days mRS shift
timeFrame: at 90±7 days
measure: discharge mRS
timeFrame: at discharge (up to 30 days)
measure: 24 hours NIHSS score
timeFrame: at 24 hours after receiving thrombolysis
measure: discharge NIHSS score
timeFrame: at discharge (up to 30 days)
measure: Rate of patients with any systematic bleeding
timeFrame: during hospital stay (up to 30 days)
measure: Rate of patients with 90 days mortality
timeFrame: at 90±7 days
measure: Rate of patients with any intracranial hemorrhage
timeFrame: during hospital stay (up to 30 days)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Chen
Study officials:
affiliation: Huashan Hospital
name: Qiang Dong
role: PRINCIPAL_INVESTIGATOR
References: