Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)

NCT05657457 | Terminated Phase 3 DMC

• 1 other identifier: Y (2022) 185
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• proportion of favorable functional outcome

  favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3

  Day 90

Secondary Outcomes (15)

• proportion of patients with an improved modified thrombolysis in cerebral infarction score

  immediately after intraarterial TNK administration or at the end of endovascular treatment

• the proportion of patients with modified Rankin Score (mRS) 0 to 1

  Day 90

• the proportion of patients with modified Rankin Score (mRS) 0 to 2

  Day 90

• ordinal distribution of modified Rankin Score (mRS)

  Day 90

• change in modified Rankin Score (mRS) compared with premorbid mRS

  Day 90

Study Arms (2)

TNK group

EXPERIMENTAL

Drug: Tenecteplase

control group

NO INTERVENTION

Interventions

Tenecteplase DRUG

intra-arterial tenecteplase

TNK group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
• National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
• Successful recanalization (mTICI 2b-3) after endovascular treatment;
• PC-ASPECTS ≥ 6 on CT;
• Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
• Modified Rankin Scale score before stroke onset ≤ 3;
• Signed informed consent by patient or their legally authorized representative.

You may not qualify if:

• baseline PC ASPECTS \< 5 on CT;
• More than six retrieval attempts in the same vessel;
• Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
• Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (\<100000/mm3), or INR \> 1.7;
• Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
• After recanalization, severe and sustained (i.e., \> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
• Patients with contraindication or allergic to any ingredient of drugs in our study
• Pregnancy, plan to get pregnant or during lactation
• The estimated life expectancy is less than 6 months due to other serious diseases;
• Other conditions unsuitable for this clinical study assessed by researcher.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead
• Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning: collaborator

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 20, 2022
• Study Start: March 21, 2023
• Primary Completion: May 18, 2025
• Study Completion: May 18, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

CN (1)