Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of… (NCT05684172) | Clinical Trial Compass
CompletedPhase 2/3
Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation
China208 participantsStarted 2023-01-24
Plain-language 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 of posterior circulation, 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 of posterior circulation 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Acute ischemic stroke patients with symptomatic intracranial large vessel occlusion (LVO) in the intracranial vertebral artery, basilar artery, or the P1 segment of the posterior cerebral artery.
* Treated with endovascular thrombectomy (EVT) resulting in an eTICI score 2b50/3 at end of the procedure.
* Age of 18 years or older;
* National Institutes of Health Stroke Scale (NIHSS) score on admission≥6;
* Posterior Circulation ASPECTS ≥ 6 on CT/CTA-Source Images/MRI-DWI.
* Time from estimated time of basilar artery occlusion to randomization\<24 hours;
* Written informed consent.
Exclusion criteria
* Pre-existing dependency with mRS \>1;
* Contraindication to Intravenous Thrombolysis (except time to therapy);
* Complete clinical recovery in the angiography suite by end of EVT procedure;
* Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive;
* Severe contrast allergy or absolute contraindication to iodinated contrast;
* Participation in other investigational drug or device clinical trials;
* Systolic pressure \>185 mmHg or diastolic pressure \>110 mmHg, and cannot be controlled by antihypertensive drugs;
* Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR \> 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours;
* platelets \<100 000/mm3, aPTT \>40 s, or PT \>15 s; Blood glucose \< 2.7 or \>22.2 mmol/L;
* Severe renal Failure as …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
a modified Rankin Score of 0-1
Timeframe: 90 (± 14 days) after procedure
Trial details
NCT IDNCT05684172
SponsorThe First Affiliated Hospital of University of Science and Technology of China