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

NCT ID: NCT07271342

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-06-30

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tenecteplase-Treated AIS Cohort

tenecteplase

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongjun Wang, MD

Role: CONTACT

yongjunwang@ncrcnd.org.cn

86-10-59978350

Other Identifiers

CSA2025KY002

Identifier Type: -

Identifier Source: org_study_id