Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)

Phase 3

Completed

• Conditions: Stroke, Ischemic
• Interventions: Drug: Tenecteplase

• Registration Number: NCT05657444
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).

The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-10
• Study First Posted: 2022-12-20
• Study Start: 2023-03-21
• Status Verified: 2025-03
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-20
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Age ≥18 years;
• Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
• The modified Rankin Scale (mRS) score before onset ≤ 2;
• ASPECTS 6 or greater on CT
• Signed informed consent.

Exclusion Criteria

• hemorrhagic stroke;
• Tandem occlusion;
• Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3);
• Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
• Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
• Patients with contraindication or allergic to any ingredient of drugs in our study;
• Pregnancy, or plan to get pregnant or during active lactation;
• Suspected septic embolus or infective endocarditis
• The estimated life expectancy is less than 6 months due to other serious diseases;
• Other conditions unsuitable for this clinical study as assessed by researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNK group	Tenecteplase	-

Primary Outcome Measures

Name	Time	Method
proportion of favorable outcome	Day 90	Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2

Secondary Outcome Measures

Name	Time	Method
proportion of excellent outcome	Day 90	Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1
proportion of successful reperfusion after the first-pass or final pass of endovascular treatment	immediately after the first-pass or final pass of endovascular treatment	Successful reperfusion is defined as defined as modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3
Distribution of modified Rankin Scale (mRS)	Day 90	mRS scores range from 0 to 6:0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
Change in cerebral circulation time after intervention	immediately after endovascular treatment
change in National Institute of Health stroke scale (NIHSS)	24 (-6/+24) hours	NIHSS scores range 0-42, with higher scores indicating greater stroke severity
occurrence rate of symptomatic intracranial hemorrhage	24 (-6/+24) hours	symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage.
occurrence rate of the distal emboli after first pass	immediately after first pass	The emboli means occlusion of the distal artery determined by DSA.
occurrence rate of early neurological improvement	24 (-6/+24) hours	early neurological improvement was defined as a 4 point or greater decrease in NIHSS
cerebral edema	24 (-6/+24) hours	cerebral edema was measured as the amount of midline shift of the brain on neuroimaging
occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events	Day 90
percentage of severe adverse events	24 (-6/+24) hours
occurrence rate of parenchymal hemorrhage	24 (-6/+24) hours	parenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
death due to all causes	Day 7 or during hospitalization
occurrence rate of extracranial hemorrhage	24 (-6/+24) hours	extracranial hemorrhage means other bleeding events except intracranial hemorrhage

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 ShenYang, China