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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
  Purpose

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.


Condition Intervention Phase
Stroke, Acute
Device: hypothermia
Other: Group1: IV t-PA and normothermia
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
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)
Arms Assigned Interventions
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
Device: hypothermia
Hypothermia is induced using the Celsius Control™ System
Other Name: cooling

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.

  Eligibility

Ages Eligible for Study:   22 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123161

Contacts
Contact: Patrick D. Lyden, MD 310-423-5166 patrick.lyden@cshs.org
Contact: Teresa Rzesiewicz, RN, MSN, PHN 858-657-7185 trzesiewicz@ucsd.edu

Locations
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: Thomas Hemmen, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: William Jones, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: David Greer, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Principal Investigator: Anna Khanna, MD         
Intercoastal Medical Group Recruiting
Sarasota, Florida, United States, 34232
Principal Investigator: Mauricia Concha, MD         
United States, Illinois
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Guy Dugan, MD         
Principal Investigator: Guy Dugan, MD         
United States, Iowa
Mercy Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Principal Investigator: Michael Jacoby, MD         
United States, Michigan
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Principal Investigator: Syed Hussain, MD         
United States, Minnesota
North Memorial Medical Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Principal Investigator: Irfan Altafullah, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Principal Investigator: Qaisar Shah, MD         
United States, Texas
Seton Medical Center Austin Recruiting
Austin, Texas, United States, 78705
Principal Investigator: J. Neil Rutledge, MD         
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: James C. Grotta, MD         
Switzerland
CHUV Recruiting
Lausanne, Switzerland
Principal Investigator: Patrik Michel, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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
  More Information

Publications:
Responsible Party: Patrick Lyden, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01123161     History of Changes
Other Study ID Numbers: ICTuS2/3, P50NS044148
Study First Received: April 27, 2010
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Cerebral Infarction
Stroke
Hypothermia
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Nervous System Diseases
Vascular Diseases
Tissue Plasminogen Activator
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents
Body Temperature Changes
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Signs and Symptoms
Fibrin Modulating Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Plasminogen
cooling
tPA
thrombolysis

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Hypothermia
Body Temperature Changes
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Agents
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Pharmacologic Actions
Hematologic Agents

ClinicalTrials.gov processed this record on August 21, 2014