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Observational RegIstry of Effectiveness and Safety of teNecTeplase in reAl worLd Settings in China
Sponsor: Beijing Tiantan Hospital
Summary
The ORIENTAL study is a prospective, multicenter, continuously enrolled real-world cohort designed to evaluate the effectiveness and safety of intravenous tenecteplase for acute ischemic stroke (AIS) in routine clinical practice across China. Approximately 10,000 patients from about 200 hospitals will be included. Eligible adults with imaging-confirmed AIS who receive tenecteplase as part of standard care will be consecutively enrolled and followed through 90 days. The study will describe patient characteristics, treatment processes, functional outcomes, and safety events, and will also explore inter-hospital variability and subgroup differences to support quality improvement and guide nationwide implementation of tenecteplase therapy.
Official title: Observational Registry of Effectiveness and Safety of Tenecteplase in Real World Settings in China-ORIENTAL
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10000
Start Date
2025-11-30
Completion Date
2029-06-30
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
tenecteplase
Intravenous administration of tenecteplase at a single weight-based dose of 0.25 mg/kg (maximum 25 mg), delivered as an intravenous bolus over 5-10 seconds as part of routine clinical care for acute ischemic stroke. Tenecteplase is used as the sole thrombolytic agent in this observational cohort and is not compared against alteplase or any other active control.
Locations (1)
Beijing Tiantan Hospital, Capital Medical University
Beijing, China