StrokeORIENTALNCT07271342
Observational RegIstry of Effectiveness and Safety of teNecTeplase in reAl worLd Settings in China
An observational study of Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- tenecteplase
- Type of treatment
- Injection or infusion
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Jun 2029
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
About this study
Official title: 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.
Read the 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
- Being tested
- tenecteplase
- Keywords
- ischemic stroke, tenecteplase, registry
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenecteplaseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase-Treated AIS Cohort | Not described Receives: Drug: tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1)
Measured: 90 days
Secondary outcomes (8)
Functional independence at 90 days (mRS score of 0-2)
Measured: 90 days
Ordinal mRS score at 90 days
Measured: 90 days
Change in NIHSS score at 24 hours compared to baseline (short-term outcome)
Measured: 24 hours
Change in NIHSS score at day 7 or discharge compared to baseline (short-term outcome)
Measured: 7 days
Symptomatic intracranial hemorrhage (sICH) within 36 hours after intravenous thrombolysis
Measured: 36 hours
All-cause mortality and time to death within 90 days
Measured: 90 days
Stroke recurrence and time to recurrence within 90 days
Measured: 90 days
Serious adverse events during hospitalization
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Nov 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271342
- Sponsor's protocol ID
- CSA2025KY002
- Acronym
- ORIENTAL
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry of Effectiveness and Safety of Tenecteplase in Real World Settings in China-ORIENTAL
- ClinicalTrials.gov ID
- NCT07271342
- Acronym / sponsor ID
- ORIENTAL / CSA2025KY002
- Conditions
- Stroke
- Keywords
- ischemic stroke, tenecteplase, registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase-Treated AIS Cohort | – | Drug: tenecteplase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenecteplaseIntravenous 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. | Drug | Tenecteplase-Treated AIS Cohort |
Primary outcome
Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1)
Time frame: 90 days
8 secondary outcomes
Functional independence at 90 days (mRS score of 0-2)
Time frame: 90 days
Ordinal mRS score at 90 days
Time frame: 90 days
Change in NIHSS score at 24 hours compared to baseline (short-term outcome)
Time frame: 24 hours
Change in NIHSS score at day 7 or discharge compared to baseline (short-term outcome)
Time frame: 7 days
Symptomatic intracranial hemorrhage (sICH) within 36 hours after intravenous thrombolysis
Time frame: 36 hours
All-cause mortality and time to death within 90 days
Time frame: 90 days
Stroke recurrence and time to recurrence within 90 days
Time frame: 90 days
Serious adverse events during hospitalization
Time frame: 7days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang, MD (86-10-59978350, yongjunwang@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.