Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| rhTNK-tPA Thrombolysis
|
Drug: rhTNK-tPA Thrombolysis
rhTNK-tPA Thrombolysis
|
Outcome Measures
Primary Outcome Measures
- Excellent functional outcome at 90 days [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
Secondary Outcome Measures
- Favorable functional outcome [3 months after thrombolysis]
proportion of mRS score 0-2 at 3 months
- Walk independence [3 months after thrombolysis]
proportion of mRS score 0-3 at 3 months
- Ordinal distribution of mRS at 90 days [3 months after thrombolysis]
Number of participants with the ordinal distribution of mRS at 90 days
- Neurological improvement at 24 hours [24 hours after thrombolysis]
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.
- NIHSS score at discharge [5-7days after thrombolysis or at discharge]
NIHSS score at 5-7 days or at discharge
- EQ-5D score at 90 days [3 months after thrombolysis]
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
- Barthel(BI) at 90 days [3 months after thrombolysis]
Global function of daily living defined as BI ≥ 95 at 90 days
Other Outcome Measures
- Symptomatic intracerebral hemorrhage at 36 hours [36 hours after thrombolysis]
symptomatic intracerebral hemorrhage as defined by ECASSIII: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration.
- Hemorrhage in other parts [36 hours after thrombolysis]
The proportion of patients with other bleeding events was defined by GUSTO bleeding at 90 days
- Mortality at 90 days [90 days after thrombolysis]
Mortality of all-cause
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Older than 18 years;
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Diagnosed as acute ischemic stroke；
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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.
Exclusion Criteria:
-
Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)；
-
Already participated in other interventional trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yunyun Xiong | Beijing | China |
Sponsors and Collaborators
- Beijing Tiantan Hospital
- National Natural Science Foundation of China
- Beijing Municipal Science & Technology Commission
- Beijing Municipal Administration of Hospitals
Investigators
- Principal Investigator: Yunyun Xiong, MD, PhD, Beijing Tiantan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY2022-236-02