Stroke, AcutePhase 2/3ICTuS2/3NCT01123161
The Intravascular Cooling in the Treatment of Stroke 2/3 Trial
A Phase 2/3 study testing hypothermia and anti-shivering treatment and Group1: IV t-PA and normothermia in people with Stroke, Acute, run by University of California, San Diego at 31 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 82 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- hypothermia and anti-shivering treatment and Group1: IV t-PA and normothermia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 31 sitesin 3 countries
- Study dates
- Jun 2010to May 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22 to 82 years old inclusive
- Patient receiving IV rt-PA using standard guidelines
- NIHSS score ≥ 7 and ≤ 20 (right hemisphere) or ≥ 7 and ≤ 24 (left hemisphere) at the time of randomization
- Pre-stroke mRS 0-1
- Able to begin endovascular phase of hypothermia within 2 hours of tPA completion
- Written Informed Consent, signed and dated by the patient (or patient's authorized representative)
Who cannot join
- Etiology other than ischemic stroke
- Item 1a on NIHSS > 1 at the time of randomization
- Clinical symptoms consistent with brainstem or cerebellar stroke
- 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
- 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
- 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 x. History of HIT (heparin induced thrombocytopenia)
Show all 15Show fewer
- Pregnancy (All women of child-bearing potential must have a negative pregnancy test, urine or blood, prior to therapy.)
- Medical conditions likely to interfere with patient assessment.
- Known allergy to meperidine or buspirone
- Currently taking or used within previous 14 days MAO-I class of medication.
- Life expectancy < 6 months
- Not likely to be available for long-term follow-up
- Use, or planned use, of intra-arterial thrombolysis, mechanical clot removal, or other experimental or approved acute therapy for this stroke event
- Chest radiograph or clinical presentation suggestive of pneumonia or clinically significant pulmonary edema at baseline.
- Temperature upon admission greater than or equal to 38°C
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
United States29 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Colorado Hospital
Aurora, Colorado, 80045
Seton Medical Center Austin
Austin, Texas, 78705
University of Alabama Hospital
Birmingham, Alabama, 35249
UT Southwestern
Dallas, Texas, 75390
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, 50314
Henry Ford Health System
Detroit, Michigan, 48202
Michigan State University
East Lansing, Michigan, 48824
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Swedish Medical Center
Englewood, Colorado, 80113
Gulf Coast Medical Center
Fort Myers, Florida, 33912
Parkview Hospital
Fort Wayne, Indiana, 46805
University of Florida
Gainesville, Florida, 32608
Hartford Hospital
Hartford, Connecticut, 06102
University of Texas Health Science Center
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
University of Miami, Jackson Memorial Hospital
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
North Memorial Medical Center
Robbinsdale, Minnesota, 55422
University of California San Diego Health System
San Diego, California, 92093
Scripps Mercy Medical Center
San Diego, California, 92103
Intercoastal Medical Group
Sarasota, Florida, 34232
Saint Louis University Medical Center
St Louis, Missouri, 63110
St. Joseph's Hospital
Tampa, Florida, 33607
University of Toledo Medical Center
Toledo, Ohio, 43614
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- hypothermia and anti-shivering treatment, Group1: IV t-PA and normothermia
- Keywords
- Hypothermia, Molecular Mechanisms of Pharmacological Action, Cerebral Infarction, Hematologic Agents, Stroke, 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
- Medical subject headings
- Stroke, Hypothermia, Cerebral Infarction, Nervous System Diseases, Vascular Diseases, Central Nervous System Diseases, Body Temperature Changes, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermia and anti-shivering treatmentDevice
Also called cooling
Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming
Group1: IV t-PA and normothermiaDrug
Group 1 will t-PA as standard of care and normothermia
| Study group | Role | What they receive |
|---|---|---|
| Group1: IV t-PA and normothermia | Active comparator | IV tpa and normothermia Receives: Drug: Group1: IV t-PA and normothermia |
| Group 2 : IV t-PA and hypothermia and anti-shivering treatment | Active comparator | IV tpa and hypothermia and anti-shivering treatment Receives: Device: hypothermia and anti-shivering treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability
Measured: 90 days
Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset
Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.
Measured: 48 hours
Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset
Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.
Measured: 48 hours
Incidence of Pneumonia
Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness
Measured: 7 days or discharge whichever comes first
90 Day Mortality
Mortality prior to the 90-day evaluation.
Measured: 90 days
Secondary outcomes (2)
The Barthel Index Measure of Activities of Daily Living;
The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.
Measured: 90 days
NIHSS Scores at 90 Days
The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2015
- Study completionMay 2015
Why it stopped: The ICTuS 2 portion of the trial has been halted and data will be analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized to normothermia or hypothermia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Patrick Lyden, Cedars-Sinai Medical Center
- Investigators
- Patrick D. Lyden, MD, Principal investigator, Cedars-Sinai Medical CenterThomas M. Hemmen, MD, PhD, Study director, University of California, San DiegoJames C. Grotta, MD, Study director, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123161
- Sponsor's protocol ID
- ICTuS2/3
- Other IDs
- P50NS044148, P50NS044227
- Acronym
- ICTuS2/3
- Status last verified
- Feb 2017
- First submitted
- 27 Apr 2010
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
PubMed 17904009Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19.
PubMed 20724711Lyden P, Ernstrom K, Raman R. Determinants of Pneumonia Risk During Endovascular Hypothermia. Ther Hypothermia Temp Manag. 2013 Mar;3(1):24-27. doi: 10.1089/ther.2012.0021.
PubMed 23667781Lyden P, Ernstrom K, Cruz-Flores S, Gomes J, Grotta J, Mullin A, Rapp K, Raman R, Wijman C, Hemmen T. Determinants of effective cooling during endovascular hypothermia. Neurocrit Care. 2012 Jun;16(3):413-20. doi: 10.1007/s12028-012-9688-y.
PubMed 22466971Guluma KZ, Liu L, Hemmen TM, Acharya AB, Rapp KS, Raman R, Lyden PD. Therapeutic hypothermia is associated with a decrease in urine output in acute stroke patients. Resuscitation. 2010 Dec;81(12):1642-7. doi: 10.1016/j.resuscitation.2010.08.003.
PubMed 20817376Guluma KZ, Hemmen TM, Olsen SE, Rapp KS, Lyden PD. A trial of therapeutic hypothermia via endovascular approach in awake patients with acute ischemic stroke: methodology. Acad Emerg Med. 2006 Aug;13(8):820-7. doi: 10.1197/j.aem.2006.03.559. Epub 2006 Jun 9.
PubMed 16766740Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.
PubMed 27834742
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01123161
- Acronym / sponsor ID
- ICTuS2/3 / ICTuS2/3
- Conditions
- Stroke, Acute
- Keywords
- Hypothermia, Molecular Mechanisms of Pharmacological Action, Cerebral Infarction, Hematologic Agents, Stroke, Nervous System Diseases, Vascular Diseases, Tissue Plasminogen Activator
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The ICTuS 2 portion of the trial has been halted and data will be analyzed.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), The University of Texas Health Science Center, Houston
- Study start
- Jun 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized to normothermia or hypothermia
| Arm | Type | Receives |
|---|---|---|
| Group1: IV t-PA and normothermia | Active comparator | Drug: Group1: IV t-PA and normothermiaIV tpa and normothermia |
| Group 2 : IV t-PA and hypothermia and anti-shivering treatment | Active comparator | Device: hypothermia and anti-shivering treatmentIV tpa and hypothermia and anti-shivering treatment |
Who may qualify
- Ages
- 22 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 22 to 82 years old inclusive
- Patient receiving IV rt-PA using standard guidelines
- NIHSS score ≥ 7 and ≤ 20 (right hemisphere) or ≥ 7 and ≤ 24 (left hemisphere) at the time of randomization
- Pre-stroke mRS 0-1
- Able to begin endovascular phase of hypothermia within 2 hours of tPA completion
Key exclusion criteria (15 listed)
- Etiology other than ischemic stroke
- Item 1a on NIHSS > 1 at the time of randomization
- Clinical symptoms consistent with brainstem or cerebellar stroke
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypothermia and anti-shivering treatmentAlso: coolingHypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming | Device | Group 2 : IV t-PA and hypothermia and anti-shivering treatment |
| Group1: IV t-PA and normothermiaGroup 1 will t-PA as standard of care and normothermia | Drug | Group1: IV t-PA and normothermia |
Primary outcome
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
Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability
Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset
Time frame: 48 hours
Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.
Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset
Time frame: 48 hours
Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.
Incidence of Pneumonia
Time frame: 7 days or discharge whichever comes first
Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness
90 Day Mortality
Time frame: 90 days
Mortality prior to the 90-day evaluation.
2 secondary outcomes
The Barthel Index Measure of Activities of Daily Living;
Time frame: 90 days
NIHSS Scores at 90 Days
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17904009Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
- Background: PubMed 20724711Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19.
- Background: PubMed 23667781Lyden P, Ernstrom K, Raman R. Determinants of Pneumonia Risk During Endovascular Hypothermia. Ther Hypothermia Temp Manag. 2013 Mar;3(1):24-27. doi: 10.1089/ther.2012.0021.
- Background: PubMed 22466971Lyden P, Ernstrom K, Cruz-Flores S, Gomes J, Grotta J, Mullin A, Rapp K, Raman R, Wijman C, Hemmen T. Determinants of effective cooling during endovascular hypothermia. Neurocrit Care. 2012 Jun;16(3):413-20. doi: 10.1007/s12028-012-9688-y.
- Background: PubMed 20817376Guluma KZ, Liu L, Hemmen TM, Acharya AB, Rapp KS, Raman R, Lyden PD. Therapeutic hypothermia is associated with a decrease in urine output in acute stroke patients. Resuscitation. 2010 Dec;81(12):1642-7. doi: 10.1016/j.resuscitation.2010.08.003.
- Background: PubMed 16766740Guluma KZ, Hemmen TM, Olsen SE, Rapp KS, Lyden PD. A trial of therapeutic hypothermia via endovascular approach in awake patients with acute ischemic stroke: methodology. Acad Emerg Med. 2006 Aug;13(8):820-7. doi: 10.1197/j.aem.2006.03.559. Epub 2006 Jun 9.
- Derived from this study: PubMed 27834742Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick D. Lyden, MD principal investigator
Cedars-Sinai Medical Center
Thomas M. Hemmen, MD, PhD study director
University of California, San Diego
James C. Grotta, MD study director
The University of Texas Health Science Center, Houston
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hypothermia and anti-shivering treatment and Group1: IV t-PA and normothermia in people with Stroke, Acute, run by University of California, San Diego at 31 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01123161, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.