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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase

Completed

Phase 3

Conditions

Stroke, Ischemic

Treatments

Drug: Tenecteplase

Study type

Interventional

Funder types

Other

Identifiers

NCT05657444

Y (2022) 168

Details and patient eligibility

About

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.

Enrollment

380 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.