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

Stroke, Ischemic Clinical Trial

Official title:

Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II): a Prospective, Randomized, Adaptive Enrichment, Open-label, Blinded End Point, Multi-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657444
• Other study ID #: Y (2022) 168
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2023
• Est. completion date: May 15, 2025

Study information

• Verified date: March 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 372
• Est. completion date: May 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• Tenecteplase
intra-arterial tenecteplase during endovascular treatment

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region	Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of favorable outcome	Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2	Day 90
Secondary	proportion of excellent outcome	Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1	Day 90
Secondary	proportion of successful reperfusion 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	immediately after the first-pass or final pass of endovascular treatment
Secondary	Distribution of modified Rankin Scale (mRS)	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.	Day 90
Secondary	Change in cerebral circulation time after intervention		immediately after endovascular treatment
Secondary	occurrence rate of early neurological improvement	early neurological improvement was defined as a 4 point or greater decrease in NIHSS	24 (-6/+24) hours
Secondary	change in National Institute of Health stroke scale (NIHSS)	NIHSS scores range 0-42, with higher scores indicating greater stroke severity	24 (-6/+24) hours
Secondary	occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events		Day 90
Secondary	occurrence rate of symptomatic intracranial hemorrhage	symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of =4 points as a result of the intracranial hemorrhage.	24 (-6/+24) hours
Secondary	occurrence rate of parenchymal hemorrhage	parenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect	24 (-6/+24) hours
Secondary	percentage of severe adverse events		24 (-6/+24) hours
Secondary	cerebral edema	cerebral edema was measured as the amount of midline shift of the brain on neuroimaging	24 (-6/+24) hours
Secondary	death due to all causes		Day 7 or during hospitalization
Secondary	occurrence rate of the distal emboli after first pass	The emboli means occlusion of the distal artery determined by DSA.	immediately after first pass
Secondary	occurrence rate of extracranial hemorrhage	extracranial hemorrhage means other bleeding events except intracranial hemorrhage	24 (-6/+24) hours