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 complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute ischemic stroke |
| Date of first enrollment | 2017/01/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Endovascular therapy Endovascular therapy intravenous tissue plasminogen |
Outcome(s)
| Primary Outcome | Rate of Modified Rankin Scale 0-2 at 90 days after onset. (Noninferior) |
|---|---|
| Secondary Outcome | Rate of asymptomatic and symptomatic intracranial hemorrhage at 24 hours after onset. |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.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
| Primary Sponsor | Nippon Medical School |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | KENTARO SUZUKI |
| Address | 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan Japan 113-8603 |
| Telephone | 03-3822-2131 |
| 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 |
| k-kimura@nms.ac.jp | |
| Affiliation | Nippon Medical School Neurology |