Intravenous Thrombolysis With Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Acute Non-large Vessel Occlusion in Extended Time Window--A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study is designed to evaluate the efficacy of IV rhTNK-tPA between 4.5 to 24 hours from symptom onset in patients presenting with a non-large vessel occlusion ischemic stroke.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical diagnosis of acute ischemic stroke

• Age≥18 years

• Pre-stroke mRS score≤1 points

• Disabling stroke defined as follows:

‣ Baseline NIHSS score 6-25 at the time of randomization,

⁃ Or NIHSS 4-5 with disabling deficit (e.g. hemianopia, aphasia, loss of hand function) as determined by the managing clinician

• Onset (last-seen-well) time to treatment time between 4.5 and 24 hours

• Written informed consent from patients or legally responsible representatives

• The presence of a Target Mismatch on CT perfusion: ischemic core volume\<50ml (defined as rCBF\<30%), mismatch ratio≥1.2 (Tmax\>6 sec lesion/core volume lesion), mismatch volume≥10ml

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Junwei Hao, MD
haojunwei@vip.163.com
01083198277
Backup
Gaoting Ma, MD
demo_doctor@163.com
18301579891
Time Frame
Start Date: 2023-06-02
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 568
Treatments
Experimental: Intravenous rhTNK-tPA
rhTNK-tPA(0.25mg/kg) given as a single, intravenous bolus immediately upon randomization. Experimental treatment will be administered as a single intravenous bolus over 5-10 seconds as per the standard manufacturers' instructions for use.
Active_comparator: Standard Medical Treatment
Antiplatelet therapy (aspirin or clopidogrel alone) at the discretion of local investigators according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
Related Therapeutic Areas
Sponsors
Collaborators: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd., Beijing Hospitals Authority
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov