Observational RegIstry of Effectiveness and Safety of teNecTeplase in reAl worLd Settings in China

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.

NCT Number	NCT07271342
Lead Sponsor	Beijing Tiantan Hospital
Conditions	Stroke
Enrollment	10,000 participants
Start Date	2025-11-30
Primary Completion	2029-03-31 (estimated)
Study Completion	2029-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-06