Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

Beijing Tiantan Hospital1,600 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,600

Conditions

Stroke, Ischemic

Interventions

rhTNK-tPA ThrombolysisDRUG

rhTNK-tPA Thrombolysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Yunyun Xiong

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 3 months after thrombolysis

Secondary Outcomes

Favorable functional outcome

proportion of mRS score 0-2 at 3 months

Time frame: 3 months after thrombolysis

Walk independence

proportion of mRS score 0-3 at 3 months

Time frame: 3 months after thrombolysis

Ordinal distribution of mRS at 90 days

Number of participants with the ordinal distribution of mRS at 90 days

Time frame: 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.

Time frame: 24 hours after thrombolysis

NIHSS score at discharge

NIHSS score at 5-7 days or at discharge

Time frame: 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

Time frame: 3 months after thrombolysis

Central Contacts

Yunyun Xiong, MD, PhD

CONTACT

00861059975213 xiongyunyun@bjtth.org

Data from ClinicalTrials.gov

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