This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score ordinal shift analysis). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 24 hours of treatment.
- Tissue plasminogen activator (Activase®)Drug
Intervention Desc: Thrombolytic
- Ultrasound Device
Intervention Desc: Medical imaging technique used to visualize muscles, tendons, and many internal organs, their size, structure and any pathological lesions with real time tomographic images.
- Placebo Drug
Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
- Perflutren Lipid Microsphere (DEFINITY)Drug
Other Names: Definity Intervention Desc: The perflutren lipid microspheres preparation contains very small gas-filled lipid microspheres that reflect the sound waves and help create a better picture.
- Transcranial ultrasound as an adjunctive therapy to tPA Device
Intervention Desc: tPA per approved labeling administered over 60 minutes Ultrasonic headframe with active insonation for 120 minutes ARM 1: Kind: Experimental Label: Target group Description: A combined treatment with transcranial US and systemic tPA
- Standard of care tPA therapy for acute ischemic stroke Drug
Intervention Desc: tPA per approved labeling administered over 60 minutes Ultrasonic headframe with sham (inactive) insonation for 120 minutes ARM 1: Kind: Experimental Label: Control group Description: Systemic tPA alone
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomized to one of two arms: combined treatment with perflutren lipid microspheres, transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke.
|Type||Measure||Time Frame||Safety Issue|
|Primary||To compare clinical recovery rates (modified Rankin score 0-1) at 3 months after stroke onset.|
|Secondary||A comparison of the rates of symptomatic intracerebral hemorrhage within 0-36 hours from initiation of treatment.|
|Primary||Modified Rankin score 0-1||3 months||Yes|
|Secondary||Symptomatic intracerebral hemorrhage||0-36 hours from treatment||Yes|
|Primary||Modified Rankin score ordinal shift analysis||3 months||Yes|