The Intravascular Cooling in the Treatment of Stroke 2/3 Trial "ICTuS2/3"

Terminated

Phase 2/3 Results N/A

Trial Description

The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.

Detailed Description

A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain. Research has shown that tissue plasminogen activator (tPA)—a naturally occurring protein that opens blocked arteries by dissolving blood clots — activates the body's ability to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a stroke.
The Food and Drug Administration (FDA) has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset.
Researchers believe that a lower body temperature (hypothermia) may be beneficial while a stroke is happening because hypothermia may prevent further brain injury, or may make the stroke less damaging.
Patients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study.
There are two study groups - tPA alone or tPA with cooling (hypothermia). Participants will be randomly assigned to one of the two study groups. Length of participation (including observation after the patient leaves the hospital) is 90 days.
This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.

Trial Stopped: The ICTuS 2 portion of the trial has been halted and data will be analyzed. The study will resume as ICTuS 3

Conditions

Interventions

  • Hypothermia Device
    Intervention Desc: Hypothermia is induced using the Celsius Control™ System
    ARM 1: Kind: Experimental
    Label: Group 2 : IV t-PA and hypothermia
  • Group1: IV t-PA and normothermia Other
    Intervention Desc: Group 1 will t-PA as standard of care and normothermia
    ARM 1: Kind: Experimental
    Label: Group1: IV t-PA and normothermia

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study.

There are two study groups - tPA alone or tPA with cooling (hypothermia). Participants will be randomly assigned to one of the two study groups. Length of participation (including observation after the patient leaves the hospital) is 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary outcome is the proportion of patients achieving a favorable outcome defined as Modified Rankin Scale score of 0 or 1, assessed 90 days after treatment
Secondary The NIH Stroke Scale measure of neurologic deficit; the Barthel Index measure of activities of daily living; the Modified Rankin Scale measure of the degree of disability or dependence in daily activities and 90 day mortality.
Primary The primary outcome is the proportion of patients achieving a favorable outcome defined as Modified Rankin Scale score of 0 or 1, assessed 90 days after treatment. 90 days No
Secondary The NIH Stroke Scale measure of neurologic deficit; the Barthel Index measure of activities of daily living; the Modified Rankin Scale measure of the degree of disability or dependence in daily activities 90 days No
Secondary 90 day mortality 90 days No

Sponsors