Real-world tenecteplase registry for adults with acute ischemic stroke in China
Official title: Observational Registry of Effectiveness and Safety of Tenecteplase in Real World Settings in China-ORIENTAL
Run by Beijing Tiantan Hospital · NCT07271342 · Data updated 2026-11-12
This registry will see how intravenous tenecteplase works and how safe it is for adults in China who have an imaging-confirmed acute ischemic stroke and receive the drug as part of routine care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | November 30, 2025 |
| Main results expected | March 31, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT07271342 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with imaging-confirmed acute ischemic stroke who receive intravenous tenecteplase at a participating hospital and can provide consent and complete follow-up are the intended participants.
✕Probably not a fit
Patients who do not receive tenecteplase, who had reperfusion therapy prior to admission, who are enrolled in conflicting interventional trials, or who cannot complete follow-up are unlikely to benefit from inclusion in this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ORIENTAL is a prospective, multicenter, real-world registry that will consecutively enroll about 10,000 adults with imaging-confirmed acute ischemic stroke treated with intravenous tenecteplase across roughly 200 hospitals in China. Participants will be followed for 90 days to capture functional outcomes, safety events, patient characteristics, and treatment processes such as door-to-needle time. The registry will document inter-hospital variability and subgroup differences to identify practice gaps and support quality improvement. Results will be compared with prior randomized trials to help interpret how tenecteplase performs in routine clinical settings.
Why it matters
Potential benefit: If successful, the registry could show whether tenecteplase is effective and safe in routine Chinese clinical practice and support wider, evidence-based use to improve stroke outcomes.
How similar studies have gone: Randomized trials and smaller observational studies have suggested tenecteplase can be as effective or more effective than alteplase for some patients, but large-scale real-world registry data in China are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Beijing Tiantan Hospital, Capital Medical University
Beijing, China Recruiting
Study contacts
- Study coordinator: Yongjun Wang, MD
- Email: yongjunwang@ncrcnd.org.cn
- Phone: 86-10-59978350
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.