Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

Tenecteplase REperfusion in Acute Ischemic sTroke Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Drug: rhTNK-tPA Thrombolysis

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 Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Yunyun Xiong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

acute ischemic stroke patients treated with rhTNK-tPA and derivatives in China.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rhTNK-tPA Thrombolysis	Drug: rhTNK-tPA Thrombolysis; rhTNK-tPA Thrombolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable functional outcome	proportion of mRS score 0-2 at 3 months	3 months after thrombolysis
Walk independence	proportion of mRS score 0-3 at 3 months	3 months after thrombolysis
Ordinal distribution of mRS at 90 days	Number of participants with the ordinal distribution of mRS at 90 days	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.	24 hours after thrombolysis
NIHSS score at discharge	NIHSS score at 5-7 days or at discharge	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	3 months after thrombolysis
Barthel(BI) at 90 days	Global function of daily living defined as BI ≥ 95 at 90 days	3 months after thrombolysis

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Hemorrhage in other parts	The proportion of patients with other bleeding events was defined by GUSTO bleeding at 90 days	36 hours after thrombolysis
Mortality at 90 days	Mortality of all-cause	90 days after thrombolysis

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: National Natural Science Foundation of China; Beijing Municipal Science & Technology Commission; Beijing Municipal Administration of Hospitals

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2023
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: thrombolysis; tenecteplase
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: KY2022-236-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No