INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy (NCT07727395) | Clinical Trial Compass
RecruitingPhase 3
INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy
Vietnam416 participantsStarted 2026-08-01
Plain-language summary
The NEWLINE trial is a multicenter, randomized, open-label, blinded endpoint (PROBE) trial evaluating whether adjunctive low-dose intra-arterial alteplase administered immediately after successful endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion. Eligible participants achieving successful reperfusion (eTICI 2b-3) within 24 hours of symptom onset will be randomized 1:1 to receive intra-arterial alteplase plus standard care or standard care alone. The primary outcome is excellent functional outcome (modified Rankin Scale score 0-1) at 90 days.
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
. Age ≥ 18 years old.
. No significant pre-stroke functional disability (pre-stroke mRS 0-1)
. Clinical diagnosis of acute ischemic stroke with anterior LVO
. Time from symptom onset to randomization within 24 hours, including wake-up stroke or unwitness stroke; the onset time refers to "Last Known Well" (LKW).
. Baseline NIHSS of 6 - 25
. Non-contrast CT (NCCT) or diffusion-weighted imaging (DWI)-MRI Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. For patients with available perfusion imaging (CTP/MRP), additional criteria include: Ischemic core volume ≤ 70mL; Mismatch volume ≥ 15 ml; Mismatch ratio ≥ 1.8
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.
1This trial is testing intra-arterial alteplase given after a mechanical thrombectomy already succeeds — my doctor has already told me thrombectomy is being considered for me, so is this kind of combination approach something that could realistically apply to my situation?
2The trial is Phase 3, which means it's testing whether this treatment actually works at scale — but the main safety concern they're measuring is symptomatic brain bleeding within 24 hours, so what does my doctor think my personal risk of that complication would be if I were to participate?
3The trial isn't recruiting yet, so if my doctor thinks this approach might be right for me, how long before it opens and would waiting affect my treatment options in the meantime?
4The primary outcome they're measuring is the Modified Rankin Scale at 90 days, which tracks how independent someone is after a stroke — based on my specific stroke and overall health, what kind of functional recovery does my doctor think is realistic whether or not I join a trial like this?
5Since standard mechanical thrombectomy is already an established treatment for large vessel occlusion strokes, can my doctor explain what the potential benefit of adding intra-arterial alteplase afterward might be, and why a patient like me might or might not be a good candidate to explore this trial once it opens?
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.
. Evidence of oclussion of the intracranial segment of the internal carotid artery (ICA), or M1 or M2 segment of the middle cerebral artery (MCA) on CT angiography (CTA) or MR angiography (MRA)
. Treated with EVT resulting eTICI score of 2b-3. Patients with an eTICI score of 2b-3 on the diagnostic cerebral angiography before MT are also eligible for the study.
Exclusion criteria
. mRS score ≥ 2 before stroke onset
. Anticipated advanced comorbid disease with life expectancy \< 12 months
. Acute head trauma
. Severe hypertension with SBP \> 185 mmHg or DBP \> 110 mmHg and refractory to treatment.
. Any active or recent major bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 30 days.
. Contraindication to recombinant human tissue plasminogen activator (rt-PA) (except time to therapy).
. Women who are pregnant at stroke onset.
. Recent intracranial surgery in the past 30 days.