NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000021488

Registered date:01/04/2016

Randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute stroke with ICA and M1 occlusion - A prospective, multicenter, randomized trial

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedAcute ischemic stroke
Date of first enrollment2017/01/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Endovascular therapy Endovascular therapy intravenous tissue plasminogen

Outcome(s)

Primary OutcomeRate of Modified Rankin Scale 0-2 at 90 days after onset. (Noninferior)
Secondary OutcomeRate of asymptomatic and symptomatic intracranial hemorrhage at 24 hours after onset.

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximum85years-old
GenderMale and Female
Include criteria
Exclude criteria1.Patients with a hypersensitivity to contrast 2.Past history of puncture artery hemostasis 3.Patients with severe urine function 4.A lactating or pregnant patients 5.Patient expected life expectancy within 90 days 6.Ineligible for tPA therapy patients 7.Patient deemed unfit to conduct this testing responsible physician or trial division

Related Information

Contact

public contact
Name KENTARO SUZUKI
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan Japan 113-8603
Telephone 03-3822-2131
E-mail kentarow@nms.ac.jp
Affiliation Nippon Medical School Neurological Science
scientific contact
Name KAZUMI KIMURA
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan Japan
Telephone 03-3822-2131
E-mail k-kimura@nms.ac.jp
Affiliation Nippon Medical School Neurology