Stroke
Conditions
Keywords
ischemic stroke, tenecteplase, registry
Brief 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.
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.
Sponsors
Beijing Tiantan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older; 2. Diagnosed with acute ischemic stroke confirmed by imaging (CT or MRI); 3. Treated with intravenous tenecteplase at the participating institution; 4. Provided written informed consent, signed by the patient or their legally authorized representative; 5. Capable of completing follow-up assessments.
Exclusion criteria
1. Received reperfusion therapy prior to the hospital admission (e.g., intravenous thrombolysis prior to admission); 2. Participating in any clinical trials where the intervention may affect the outcomes of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1) | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Ordinal mRS score at 90 days | 90 days |
| Change in NIHSS score at 24 hours compared to baseline (short-term outcome) | 24 hours |
| Change in NIHSS score at day 7 or discharge compared to baseline (short-term outcome) | 7 days |
| Functional independence at 90 days (mRS score of 0-2) | 90 days |
| All-cause mortality and time to death within 90 days | 90 days |
| Stroke recurrence and time to recurrence within 90 days | 90 days |
| Serious adverse events during hospitalization | 7days |
| Symptomatic intracranial hemorrhage (sICH) within 36 hours after intravenous thrombolysis | 36 hours |
Countries
China
Contacts
Primary ContactYongjun Wang, MD
Outcome results
None listed