Health Trials

INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy

ConditionsStroke, Acute IschemicLarge Vessel OcclusionThrombectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
Sponsor115 People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alteplase

    Drug

    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

    Device

    Endovascular thrombectomy performed according to current international and local guidelines using approved endovascular techniques and devices.

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: Standard medical treatmentActive comparator 1 intervention
Group B: Adjunct intra-arterial thrombolysis following successful thrombectomyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

SAFETY OUTCOME: Mortality at 90 days

Mortality at 90 days

Time frame
Day 90 post endovascular treatment
3

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
4

NIHSS at 24h

The proportion of NIHSS 0-1 or ≥10 points reduction at 24 ±12 hours

Time frame
24 ±12 hours post EVT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

115 People's Hospital

Lead sponsor

Ho Chi Minh City Stroke Association

Collaborator

Source ClinicalTrials.gov
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