Imaging-based Thrombolysis Trial in Acute Ischemic Stroke "ITAIS"

Completed

Phase N/A Results

Trial Description

To assess through use of MRI, the efficacy and safety of intra-arterial and intravenous thrombolysis in acute ischemic stroke patients within 3-9 hours time window.

Interventions

Trial Design

Prospective, multi-center, randomized, open, assessor-blind study.

Patient Involvement

Patients in 3-6 hours time window receive intravenous or intravenous thrombolysis with rt-PA randomly. Patients in 6-9 hours time window receive intravenous thrombolysis or conventional therapy randomly. All enrolled patients have standardized DWI, PWI and MRA.

Outcomes

Type Measure Time Frame Safety Issue
Primary Reperfusion, assessed 24 to 48 hours post treatment and defined as either ?30% reduction of MTT volume of abnormality or ?2 points improvement on the TICI grading scheme using MRA.
Secondary The combined analysis of the NIHSS, modified Rankin scale (mRS), and Barthel Index (BI) defined as?8 points improvement or scoring 0 to 1 on the NIHSS, a score of 0 to 2 on mRS, and a BI score of 75 to 100 at 90 days.

Sponsors

Ministry of Science and Technology of the People´s Republic of China