MedTrace Logo

INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy

NCT07727395 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • Stroke, Acute Ischemic
  • Large Vessel Occlusion
  • Thrombectomy

Interventions

DRUG

Alteplase

Intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) administered immediately after successful endovascular thrombectomy in addition to best medical management.

DEVICE

Endovascular thrombectomy

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

Sponsors & Collaborators

  • Ho Chi Minh City Stroke Association

    collaborator OTHER_GOV

  • 115 People's Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727395 on ClinicalTrials.gov