Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China

Ischemic Stroke Clinical Trial

— TTT-AIS CHINA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078995
• Other study ID #: 20230726
• Status: Recruiting
• Start date: April 2, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: Huashan Hospital
• Contact: Qiang Dong, M.D. Ph.D.
• Phone: 86-021-52887142
• Email: qiang_dong163[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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%

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Tenecteplase
Thrombolysis wtih rhTNK-tPA
• Alteplase
Thrombolysis wtih rt-PA

Locations

Country	Name	City	State
China	Xin Chen	Shanghai

Sponsors (19)

Lead Sponsor

Collaborator

Huashan Hospital

Jilin Liuhe Hospital, Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum, Nanshi Hospital of Nanyang, Ruijin Hospital Luwan Branch, Shanghai 10th People's Hospital, Shanghai Deji Hospital, Shanghai East Hospita, Shanghai Fifth People's Hospital, Shanghai Fourth People's Hospital, Shanghai Neuromedical Center, Shanghai Ninth People's Hospital Huangpu Branch, Shanghai Pudong Gongli hospital, Shanghai Pudong People's Hospital, Shanghai Putuo Liqun Hospital, Shenyang Fifth People's hospital, Shenyang Fushun general hospital of mining bureau, The First Affiliated Hospital of Ningbo University, Yantai Affliated Hosiptal of Binzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with symptomatic intracranial hemorrhage within 36 hours	Clinical deterioration or neurological decline causing an increase in NIHSS score of =4 points due to intracranial hemorrhage confirmed by brain imaging	36 hours
Secondary	90 days mRS 0-1	modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.	at 90±7 days
Secondary	90 days mRS shift	a shift analysis of the distribution of modified Rankin Scale score which measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.	at 90±7 days
Secondary	discharge mRS	modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.	at discharge (up to 30 days)
Secondary	24 hours NIHSS score	The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.	at 24 hours after receiving thrombolysis
Secondary	discharge NIHSS score	The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.	at discharge (up to 30 days)
Secondary	Rate of patients with any systematic bleeding	Rate of patients with any systematic bleeding requiring blood infusion during hospital stay reflecting short term safety outcome	during hospital stay (up to 30 days)
Secondary	Rate of patients with 90 days mortality	Rate of patients with all-cause mortality within 90 days reflecting safety outcome	at 90±7 days
Secondary	Rate of patients with any intracranial hemorrhage	Rate of patients with any intracranial hemorrhage without significant neurological deterioration on the brain imaging reflecting short term safety outcome	during hospital stay (up to 30 days)