The Intravascular Cooling in the Treatment of Stroke 2/3 Trial (ICTuS2/3)
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.
Other: Group1: IV t-PA and normothermia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke|
- 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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- 90 day mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Group1: IV t-PA and normothermia
IV tpa and normothermia
Other: Group1: IV t-PA and normothermia
Group 1 will t-PA as standard of care and normothermia
Active Comparator: Group 2 : IV t-PA and hypothermia
IV tpa and hypothermia
Hypothermia is induced using the Celsius Control™ System
Other Name: cooling
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.
|Contact: Patrick D. Lyden, MDfirstname.lastname@example.org|
|Contact: Teresa Rzesiewicz, RN, MSN, PHNemail@example.com|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Principal Investigator: Patrick D. Lyden, MD|
|University of California||Recruiting|
|San Diego, California, United States, 92093|
|Principal Investigator: Thomas M. Hemmen, MD, PhD|
|Scripps Mercy Medical Center||Recruiting|
|San Diego, California, United States, 92103|
|Principal Investigator: Gilda Tafreshi, MD|
|United States, Florida|
|Intercoastal Medical Group||Recruiting|
|Sarasota, Florida, United States, 34232|
|Principal Investigator: Mauricia Concha, MD|
|United States, Minnesota|
|North Memorial Medical Center||Recruiting|
|Robbinsdale, Minnesota, United States, 55422|
|Principal Investigator: Irfan Altafullah, MD|
|United States, Texas|
|University of Texas Health Science Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: James C. Grotta, MD|
|Principal Investigator:||Patrick D. Lyden, MD||Cedars-Sinai Medical Center|
|Study Director:||Thomas M. Hemmen, MD, PhD||University of California, San Diego|
|Study Director:||James C. Grotta, MD||The University of Texas Health Science Center, Houston|