INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy
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
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
Treatments tested in this trial
- Alteplase
- Endovascular thrombectomy
Treatment groups
416 Participants
are divided into 2 treatment groupsSponsors and collaborators
115 People's Hospital
Lead sponsor
Ho Chi Minh City Stroke Association
Collaborator
Source ClinicalTrials.gov