A Phase 3 interventional study of Alteplase and Endovascular thrombectomy in Stroke, Acute Ischemic, Large Vessel Occlusion and Thrombectomy, sponsored by 115 People's Hospital. Recruiting at 13 sites in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by 115 People's Hospital · Phase 3, Interventional, and Treatment
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.
Acute ischemic stroke caused by anterior circulation large vessel occlusion is commonly treated with endovascular thrombectomy (EVT), which achieves successful reperfusion in approximately 85-90% of treated patients. Despite successful reperfusion, many patients remain functionally disabled because of persistent microvascular obstruction, distal embolization, incomplete tissue reperfusion (the "no-reflow" phenomenon), and ischemia-reperfusion injury.
The NEWLINE trial is a prospective, multicenter, randomized, open-label, blinded endpoint (PROBE) trial designed to evaluate whether adjunctive low-dose intra-arterial alteplase administered immediately after successful EVT improves functional outcomes compared with standard medical care alone. Eligible adults with acute ischemic stroke due to anterior circulation large vessel occlusion who achieve successful reperfusion (expanded Thrombolysis in Cerebral Infarction [eTICI] grade 2b-3) within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either adjunctive intra-arterial alteplase plus standard care or standard care alone.
The primary efficacy outcome is the proportion of participants achieving excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1, at 90 days after randomization. Key safety outcomes include symptomatic intracranial hemorrhage and all-cause mortality. The trial aims to determine whether adjunctive intra-arterial alteplase enhances neurological recovery after successful EVT without increasing the risk of major hemorrhagic complications or death.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 416 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →115 People's Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endovascular thrombectomy + Best Medical Management
Device: Endovascular thrombectomy
Endovascular thrombectomy + Adjunct intra-arterial alteplase + Best Medical Management
Drug: Alteplase · Device: Endovascular thrombectomy
Intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) administered immediately after successful endovascular thrombectomy in addition to best medical management.
Endovascular thrombectomy performed according to current international and local guidelines using approved endovascular techniques and devices.
Modified Rankin Scale at day 90
Proportion of participants achieving a Modified Rankin Scale (mRS) score of 0 or 1 at 90 days (±15 days). The Modified Rankin Scale ranges from 0 (no symptoms) to 6 (death). Lower scores indicate better functional outcomes; higher scores indicate worse disability.
Time frame: 90 days post treatment
SAFETY OUTCOME: symptomatic intracerebral hemorrahge (sICH ) rate at 24 hours.
Symptomatic intracranial hemorrhage (sICH) will be classified according to the Heidelberg Bleeding Classification.
Time frame: 24hours post EVT
The shift analysis of 90-day mRS
Shift analysis of the modified Rankin Scale (mRS) at Day 90 (scores range from 0 to 6, with mRS scores of 5 and 6 combined into a single category representing a very poor outcome; higher scores indicate worse functional outcomes).
Time frame: day 90 post treatment
SAFETY OUTCOME: Mortality at 90 days
Mortality at 90 days
Time frame: Day 90 post endovascular treatment
Quality of life at 90 days
Quality of life at 90 days (±15 days), measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better health-related quality of life.
Time frame: day 90 post treatment
NIHSS at 24h
The proportion of NIHSS 0-1 or ≥10 points reduction at 24 ±12 hours
Time frame: 24 ±12 hours post EVT
mRS 0-2 at 90 day
The proportion of mRS 0-2 at 90 ± 15 days
Time frame: 90 day post EVT
Any ICH
Any ICH within 24 ± 12 hours (Heidelberg criteria)
Time frame: 24 hour post EVT
Final eTICI reperfusion grade
Reperfusion will be assessed on the final digital subtraction angiogram using the expanded Thrombolysis in Cerebral Infarction (eTICI) grading scale. The eTICI scale ranges from 0 (no reperfusion) to 3 (complete reperfusion). Higher grades indicate better angiographic reperfusion.
Time frame: Immediately after completion of intra-arterial alteplase administration.
To evaluate the incremental cost-effectiveness and cost-utility of adjunctive intra-arterial thrombolysis following successful angiographic reperfusion.
Incremental cost-effectiveness and cost-utility of adjunctive intra-arterial thrombolysis following successful angiographic reperfusion, expressed as the incremental cost per quality-adjusted life-year (QALY) gained compared with standard care.
Time frame: 12 months ± 1 month
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in the primary publication will be shared. This includes baseline demographic and clinical characteristics, imaging variables, treatment allocation, efficacy outcomes, safety outcomes, and follow-up data collected through 90 days.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 12 months after publication of the primary study results and continuing for 10 years.
Access criteria: Qualified researchers with a methodologically sound research proposal may request access to de-identified individual participant data and supporting documents. Requests will be reviewed and approved by the Steering Committee. Access will be granted after execution of a data-sharing agreement and provided through a secure data-sharing platform or secure file transfer.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 143 non-industry phase 3 interventional studies under Ischemic Stroke, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 28 months is below that.
Counting every sponsor, half of 165 studies reached it within 30 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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