Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke : a Multicenter, Prospective, Observational, Real-world Study(TRANSIT)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Ischemic strokes account for 60-70% of all strokes worldwide and are severely debilitating, drawing considerable attention due to their high prevalence.The majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studies.The aim of this study is to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in clinical practice. This study aimed to establish a foundation for refining intravenous thrombolytic therapy tailored to various patient profiles and to guide clinicians in selecting the most suitable thrombolytic treatment options.

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

• \- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal.

• 3\. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.

Locations
Other Locations
China
Tianjin Huanhu Hospital
RECRUITING
Tianjin
Contact Information
Primary
Shoufeng Liu, MD
shoufengliu2010@163.com
400-802-7885
Backup
Yalin Guan, MD
guanyalinhh@126.com
400-802-7885
Time Frame
Start Date: 2024-10-26
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 6000
Treatments
TNK group
The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg.
rtPA group
The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Huanhu Hospital

This content was sourced from clinicaltrials.gov