Stroke, IschemicNCT05724342
Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）
An observational study of Stroke, Ischemic, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- rhTNK-tPA Thrombolysis
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: acute ischemic stroke patients treated with rhTNK-tPA and derivatives in China.
Who may be able to join
- Older than 18 years;
- Diagnosed as acute ischemic stroke；
- Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)；
- Thrombolysis with rhTNK-tPA and derivatives.
Who cannot join
- Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)；
- Already participated in other interventional trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yunyun Xiong
Beijing
Yunyun Xiong, xiongyunyun@bjtth.org
About this study
Official title: Tenecteplase REperfusion in Acute Ischemic sTroke Registry
The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.
Read the detailed description
Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient.
This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.
- Conditions
- Stroke, Ischemic
- Being tested
- rhTNK-tPA Thrombolysis
- Keywords
- thrombolysis, tenecteplase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNK-tPA ThrombolysisDrug
rhTNK-tPA Thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| rhTNK-tPA Thrombolysis | Not described Receives: Drug: rhTNK-tPA Thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent functional outcome at 90 days
proportion of mRS score 0-1 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome
Measured: 3 months after thrombolysis
Secondary outcomes (7)
Favorable functional outcome
proportion of mRS score 0-2 at 3 months
Measured: 3 months after thrombolysis
Walk independence
proportion of mRS score 0-3 at 3 months
Measured: 3 months after thrombolysis
Ordinal distribution of mRS at 90 days
Number of participants with the ordinal distribution of mRS at 90 days
Measured: 3 months after thrombolysis
Neurological improvement at 24 hours
NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment.
Measured: 24 hours after thrombolysis
NIHSS score at discharge
NIHSS score at 5-7 days or at discharge
Measured: 5-7days after thrombolysis or at discharge
EQ-5D score at 90 days
EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome
Measured: 3 months after thrombolysis
Barthel(BI) at 90 days
Global function of daily living defined as BI ≥ 95 at 90 days
Measured: 3 months after thrombolysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Municipal Science & Technology Commission, Beijing Municipal Administration of Hospitals
- Responsible party
- Principal investigator, Yunyun Xiong, Beijing Tiantan Hospital
- Investigators
- Yunyun Xiong, MD, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724342
- Sponsor's protocol ID
- KY2022-236-02
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase REperfusion in Acute Ischemic sTroke Registry
- ClinicalTrials.gov ID
- NCT05724342
- Acronym / sponsor ID
- KY2022-236-02
- Conditions
- Stroke, Ischemic
- Keywords
- thrombolysis, tenecteplase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Municipal Science & Technology Commission, Beijing Municipal Administration of Hospitals
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Feb 2023 (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 aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.
Detailed description
Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient.
This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhTNK-tPA Thrombolysis | – | Drug: rhTNK-tPA Thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute ischemic stroke patients treated with rhTNK-tPA and derivatives in China.
Key inclusion criteria (4 listed)
- Older than 18 years;
- Diagnosed as acute ischemic stroke；
- Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)；
- Thrombolysis with rhTNK-tPA and derivatives.
Key exclusion criteria (2 listed)
- Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)；
- Already participated in other interventional trials.
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 |
|---|---|---|
| rhTNK-tPA ThrombolysisrhTNK-tPA Thrombolysis | Drug | rhTNK-tPA Thrombolysis |
Primary outcome
Excellent functional outcome at 90 days
Time frame: 3 months after thrombolysis
proportion of mRS score 0-1 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome
7 secondary outcomes
Favorable functional outcome
Time frame: 3 months after thrombolysis
Walk independence
Time frame: 3 months after thrombolysis
Ordinal distribution of mRS at 90 days
Time frame: 3 months after thrombolysis
Neurological improvement at 24 hours
Time frame: 24 hours after thrombolysis
NIHSS score at discharge
Time frame: 5-7days after thrombolysis or at discharge
EQ-5D score at 90 days
Time frame: 3 months after thrombolysis
Barthel(BI) at 90 days
Time frame: 3 months after thrombolysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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. This study is not recruiting at the moment.
Yunyun Xiong, MD, PhD principal investigator
Beijing Tiantan Hospital
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, Ischemic, 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 4 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunyun Xiong, MD, PhD (00861059975213, xiongyunyun@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent functional outcome at 90 days (time frame: 3 months after thrombolysis). 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 15 Feb 2023.