Clinical trial NCT05657444: Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke, Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
Collaborators: name: Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
First posted: 2022-12-20
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: proportion of favorable outcome
timeFrame: Day 90
Secondary outcomes:
measure: proportion of excellent outcome
timeFrame: Day 90
measure: proportion of successful reperfusion after the first-pass or final pass of endovascular treatment
timeFrame: immediately after the first-pass or final pass of endovascular treatment
measure: Distribution of modified Rankin Scale (mRS)
timeFrame: Day 90
measure: Change in cerebral circulation time after intervention
timeFrame: immediately after endovascular treatment
measure: occurrence rate of early neurological improvement
timeFrame: 24 (-6/+24) hours
measure: change in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 (-6/+24) hours
measure: occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
timeFrame: Day 90
measure: occurrence rate of symptomatic intracranial hemorrhage
timeFrame: 24 (-6/+24) hours
measure: occurrence rate of parenchymal hemorrhage
timeFrame: 24 (-6/+24) hours
measure: percentage of severe adverse events
timeFrame: 24 (-6/+24) hours
measure: cerebral edema
timeFrame: 24 (-6/+24) hours
measure: death due to all causes
timeFrame: Day 7 or during hospitalization
measure: occurrence rate of the distal emboli after first pass
timeFrame: immediately after first pass
measure: occurrence rate of extracranial hemorrhage
timeFrame: 24 (-6/+24) hours
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References: