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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Drug: tenecteplase

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Yongjun Wang, MD; Phone Number: 86-10-59978350; Email: yongjunwang@ncrcnd.org.cn

Study Locations

• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with acute ischemic stroke who receive intravenous tenecteplase as part of routine clinical care at participating hospitals across China. The study population reflects a broad real-world stroke population, including patients with diverse comorbidities, stroke severities, and treatment pathways. Consecutive enrollment from approximately 200 centers ensures representative coverage of different geographic regions and hospital levels.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tenecteplase-Treated AIS Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1)	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional independence at 90 days (mRS score of 0-2)	90 days
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
Symptomatic intracranial hemorrhage (sICH) within 36 hours after intravenous thrombolysis	36 hours
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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ischemic stroke; tenecteplase; registry
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Amino Acids, Peptides, and Proteins; Proteins; Hydrolases; Enzymes; Enzymes and Coenzymes; Blood Proteins; Endopeptidases; Peptide Hydrolases; Serine Endopeptidases; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Tissue Plasminogen Activator; Tenecteplase
• Other Study ID Numbers: CSA2025KY002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No