Trial of Intra-arterial Tenecteplase Following Successful Endovascular Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Rationale: Recently, one prospective multicenter RCT reported a potential beneficial effect of intra-arterial alteplase following successful endovascular thrombectomy (EVT) in patients with an acute intracranial large vessel occlusion. In 2018, another prospective multicenter RCT supported the superiority of tenecteplase over alteplase in ischemic stroke patients with large vessel occlusion.

Objective: To assess the effect of EVT in addition to intra-arterial tenecteplase compared to EVT alone, in patients with large vessel occlusion, on functional and safety outcomes.

Study design: This is a parallel group, randomized clinical trial of EVT with IA-TNK versus EVT. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow-up.

Study population: Patients with acute intracranial large vessel occlusion and an eTICI 2b-3 after EVT.

Main study parameters/outcomes: The primary effect parameter will be excellent functional status at day 90 defined as a modified Rankin Score (mRS) of 0-1. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of University of Science and Technology of China
• Treatments: Tenecteplase

Criteria

Inclusion criteria

1. Patients with symptomatic intracranial large vessel occlusion (LVO) involving the intracranial ICA, MCA-M1 or -M2 segments, basilar artery, or vertebral artery (if that completely blocks the antegrade flow to the basilar artery) treated with endovascular thrombectomy (EVT) resulting in an eTICI score 2b/3 at end of the procedure.

2. Age of 18 years or older;

3. National Institutes of Health Stroke Scale (NIHSS) score on admission≥6;

4. Limited Ischemic Burden defined as following:

1. Anterior Circulation Occlusions: ASPECTS ≥ 6 on non-contrast CT or ≥ 5 on MRI-DWI.

2. Posterior Circulation Occlusions: ASPECTS ≥ 6 on CTA-Source Images/MRI-DWI.

5. Time from symptom onset to randomization<24 hours, defined as the point in time the patient was last seen well;

6. Written informed consent. Exclusion criteria

1) Pre-existing dependency with mRS >1; 2) Contraindication to Intravenous Thrombolysis (except time to therapy); 3) Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive; 4) Severe contrast allergy or absolute contraindication to iodinated contrast; 5) Participation in other clinical trials; 6) Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs; 7) Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; 8) platelets <100 000/mm3, aPTT >40 s, or PT >15 s; Blood glucose < 2.7 or >22.2 mmol/L; 9) Life expectancy < 1 year; 10) Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.)； 11) CT/MR shows intracranial hemorrhage; 12) Ischemic stroke within 3 months; 13) Severe head trauma within 3 months.