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NOT YET RECRUITING
NCT07727395
PHASE3

INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy

Sponsor: 115 People's Hospital

View on ClinicalTrials.gov

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 functional independence (modified Rankin Scale score 0-1) at 90 days.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

416

Start Date

2026-08-01

Completion Date

2028-12-31

Last Updated

2026-07-27

Healthy Volunteers

No

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.

Locations (9)

Can Tho Central General Hospital

Can Tho, Vietnam

Da Nang Hospital

Da Nang, Vietnam

Viet Tiep Friendship Hospital

Haiphong, Vietnam

Hanoi Medical University Hospital

Hà Nội, Vietnam

Military Hospital 103

Hà Nội, Vietnam

175 Military Hospital

Ho Chi Minh City, Vietnam

People's Hospital 115

Ho Chi Minh City, Vietnam

Thong Nhat Hospital

Ho Chi Minh City, Vietnam

Hue Central Hospital

Huế, Vietnam