Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

Recruiting

• Conditions: Stroke, Ischemic
• Interventions: Drug: rhTNK-tPA Thrombolysis

• Registration Number: NCT05724342
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Last Update Submitted: 2023-02-14
• Study Start: 2023-02-15
• Last Update Posted: 2023-02-15
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rhTNK-tPA Thrombolysis	rhTNK-tPA Thrombolysis	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Barthel(BI) at 90 days	3 months after thrombolysis	Global function of daily living defined as BI ≥ 95 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
Ordinal distribution of mRS at 90 days	3 months after thrombolysis	Number of participants with the ordinal distribution of mRS 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

Trial Locations

Locations (1)

Yunyun Xiong; 🇨🇳 Beijing, China