Stroke, Ischemic
Conditions
Keywords
thrombolysis, tenecteplase
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.
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.
Interventions
DRUGrhTNK-tPA Thrombolysis
rhTNK-tPA Thrombolysis
Sponsors
National Natural Science Foundation of China
Beijing Municipal Science & Technology Commission
Beijing Municipal Administration of Hospitals
Beijing Tiantan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)； * Already participated in other interventional trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ordinal distribution of mRS at 90 days | 3 months after thrombolysis | Number of participants with the ordinal distribution of mRS at 90 days |
| 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 |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality at 90 days | 90 days after thrombolysis | Mortality of all-cause |
| 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 |
Countries
China
Contacts
Primary ContactYunyun Xiong, MD, PhD
Outcome results
None listed