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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patrick Lyden, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01123161
First received: April 27, 2010
Last updated: June 3, 2014
Last verified: June 2014

April 27, 2010
June 3, 2014
June 2010
November 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01123161 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Intravascular Cooling in the Treatment of Stroke 2/3 Trial
Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke, Acute
  • Device: hypothermia
    Hypothermia is induced using the Celsius Control™ System
    Other Name: cooling
  • Other: Group1: IV t-PA and normothermia
    Group 1 will t-PA as standard of care and normothermia
  • Active Comparator: Group1: IV t-PA and normothermia
    IV tpa and normothermia
    Intervention: Other: Group1: IV t-PA and normothermia
  • Active Comparator: Group 2 : IV t-PA and hypothermia
    IV tpa and hypothermia
    Intervention: Device: hypothermia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2017
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 22 to 82 years old inclusive
  2. Patient receiving IV rt-PA using standard guidelines (Appendix II) Page 23
  3. NIHSS score ≥ 7 and ≤ 20 (right hemisphere) or ≥ 7 and ≤ 24 (left hemisphere) at the time of randomization
  4. Pre-stroke mRS 0-1
  5. Able to begin endovascular phase of hypothermia within 2 hours of tPA completion
  6. Written Informed Consent, signed and dated by the patient (or patient's authorized representative)

Exclusion Criteria:

  1. Etiology other than ischemic stroke
  2. Item 1a on NIHSS > 1 at the time of randomization
  3. Clinical symptoms consistent with brainstem or cerebellar stroke
  4. Classic lacunar syndrome with imaging confirmation of small deep ischemia, but randomization will not be delayed for neuroimaging other than initial scan to exclude hemorrhage
  5. Known contraindications to hypothermia, such as known hematologic dyscrasias that affect thrombosis (cryoglobulinemia, Sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thromboangiitis obliterans
  6. Known co-morbid conditions that are likely to complicate therapy in the opinion of the investigator, e.g., i. Heart failure (NYHA class III and IV)* ii. Uncompensated arrhythmia iii. Severe Liver disease iv. History of pelvic or abdominal mass likely to compress inferior vena cava v. IVC filters vi. HIV positive vii. Clinically active hypo or hyperthyroidism viii. Renal insufficiency likely to impair meperidine clearance ix. Chronic ethanol abuse
  7. Pregnancy (All women of child-bearing potential must have a negative pregnancy test, urine or blood, prior to therapy.)
  8. Medical conditions likely to interfere with patient assessment.
  9. Known allergy to meperidine or buspirone
  10. Currently taking or used within previous 14 days MAO-I class of medication.
  11. Life expectancy < 6 months
  12. Not likely to be available for long-term follow-up
  13. Use, or planned use, of intra-arterial thrombolysis, mechanical clot removal, or other experimental or approved acute therapy for this stroke event
  14. Chest radiograph or clinical presentation suggestive of pneumonia at baseline.
  15. Temperature upon admission greater than or equal to 38°C
Both
22 Years to 82 Years
No
Contact: Patrick D. Lyden, MD 310-423-5166 patrick.lyden@cshs.org
Contact: Teresa Rzesiewicz, RN, MSN, PHN 858-657-7185 trzesiewicz@ucsd.edu
United States,   Switzerland
 
NCT01123161
ICTuS2/3, P50NS044148
Yes
Patrick Lyden, Cedars-Sinai Medical Center
University of California, San Diego
National Institute of Neurological Disorders and Stroke (NINDS)
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
University of California, San Diego
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP