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Observational Registry of Effectiveness and Safety of Tenecteplase in Real World Settings in China-ORIENTAL

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

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

• Adults aged 18 years or older;

• Diagnosed with acute ischemic stroke confirmed by imaging (CT or MRI);

• Treated with intravenous tenecteplase at the participating institution;

• Provided written informed consent, signed by the patient or their legally authorized representative;

• Capable of completing follow-up assessments.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Yongjun Wang, MD
yongjunwang@ncrcnd.org.cn
86-10-59978350
Time Frame
Start Date: 2025-11-30
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 10000
Treatments
Tenecteplase-Treated AIS Cohort
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov