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

NCT ID: NCT05657444

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2025-03-20

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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TNK group

Group Type: EXPERIMENTAL

Tenecteplase

Intervention Type: DRUG

intra-arterial tenecteplase during endovascular treatment

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tenecteplase

intra-arterial tenecteplase during endovascular treatment

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

UNKNOWN

Sponsor Role: collaborator

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Head of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

Other Identifiers

Y (2022) 168

Identifier Type: -

Identifier Source: org_study_id