RecruitingNCT07271342

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

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

Sponsor

Beijing Tiantan Hospital

Enrollment

10,000 participants

Start Date

Nov 30, 2025

Study Type

OBSERVATIONAL

Conditions

Stroke

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

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria2

Received reperfusion therapy prior to the hospital admission (e.g., intravenous thrombolysis prior to admission);
Participating in any clinical trials where the intervention may affect the outcomes of this study.

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Interventions

DRUGtenecteplase

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.