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

NCT07271342 | Recruiting DMC FDA Drug

• 1 other identifier: CSA2025KY002
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

ischemic stroke; tenecteplase; registry

Outcome Measures

Primary Outcomes (1)

• Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1)

  90 days

Secondary Outcomes (8)

• 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

Study Arms (1)

Tenecteplase-Treated AIS Cohort

Drug: tenecteplase

Interventions

tenecteplase 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.

Tenecteplase-Treated AIS Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yongjun Wang, MD

CONTACT

86-10-59978350; yongjunwang@ncrcnd.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 9, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (1)