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
- Conditions
- Acute ischemic stroke
- Registration Number
- JPRN-UMIN000021488
- Lead Sponsor
- ippon Medical School
- Brief Summary
Among 204 patients (median age, 74 years; 62.7% men; median National Institutes of Health Stroke Scale score, 18), all patients completed the trial. Favorable outcome occurred in 60 patients (59.4%) in the mechanical thrombectomy alone group and 59 patients (57.3%) in the combined intravenous thrombolysis plus mechanical thrombectomy group, with nosignificant between-group difference ( P = .18 for noninferiority).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 204
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Modified Rankin Scale 0-2 at 90 days after onset. (Noninferior)
- Secondary Outcome Measures
Name Time Method Rate of asymptomatic and symptomatic intracranial hemorrhage at 24 hours after onset.