Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

Stroke, Ischemic Clinical Trial

Official title:

Tenecteplase REperfusion in Acute Ischemic sTroke Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724342
• Other study ID #: KY2022-236-02
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Beijing Tiantan Hospital
• Contact: Yunyun Xiong, MD, PhD
• Phone: 00861059975213
• Email: xiongyunyun[@]bjtth.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• rhTNK-tPA Thrombolysis
rhTNK-tPA Thrombolysis

Locations

Country	Name	City	State
China	Yunyun Xiong	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Municipal Administration of Hospitals, Beijing Municipal Science & Technology Commission, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic intracerebral hemorrhage at 36 hours	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.	36 hours after thrombolysis
Other	Hemorrhage in other parts	The proportion of patients with other bleeding events was defined by GUSTO bleeding at 90 days	36 hours after thrombolysis
Other	Mortality at 90 days	Mortality of all-cause	90 days after thrombolysis
Primary	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	3 months after thrombolysis
Secondary	Favorable functional outcome	proportion of mRS score 0-2 at 3 months	3 months after thrombolysis
Secondary	Walk independence	proportion of mRS score 0-3 at 3 months	3 months after thrombolysis
Secondary	Ordinal distribution of mRS at 90 days	Number of participants with the ordinal distribution of mRS at 90 days	3 months after thrombolysis
Secondary	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.	24 hours after thrombolysis
Secondary	NIHSS score at discharge	NIHSS score at 5-7 days or at discharge	5-7days after thrombolysis or at discharge
Secondary	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	3 months after thrombolysis
Secondary	Barthel(BI) at 90 days	Global function of daily living defined as BI = 95 at 90 days	3 months after thrombolysis