NCT07271342

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This real-world observational registry aims to generate comprehensive and high-quality evidence on the use of intravenous tenecteplase for acute ischemic stroke (AIS) in China following the national approval of the drug. Unlike randomized controlled trials with strict eligibility criteria, this study captures a broad clinical spectrum of patients and care settings, reflecting the actual patterns, challenges, and variations in stroke management across the country. The registry is designed to provide insights into how tenecteplase performs in routine practice, including patients with multiple comorbidities, diverse stroke etiologies, and differing hospital capabilities. Consecutive enrollment and continuous data capture ensure representativeness and minimize selection bias. Beyond describing effectiveness and safety, the study evaluates the real-world processes surrounding thrombolysis, including workflow metrics such as door-to-needle time and access to reperfusion resources. Analyses across different regions, hospital levels, and clinical subgroups will help identify practice gaps and opportunities for nationwide quality improvement. Comparisons with previous phase III trial populations, including the ORIGINAL study, will allow assessment of potential channeling bias and help interpret differences between clinical trial efficacy and real-world effectiveness. The results of this registry will support clinical decision-making, inform guideline updates, and contribute to establishing standardized stroke care pathways for tenecteplase in China. The large sample size and national coverage are intended to ensure sufficient precision for outcome estimation and enable robust exploratory analyses that can guide future research and policy development.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-11-30
• Primary completion: 2029-03-31
• Completion: 2029-06-30
• First posted: 2025-12-09
• Last updated: 2026-01-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study