Ischemic StrokePhase 2RECCLAIM-IINCT02411877
REperfusion With Cooling in CerebraL Acute IscheMia II
A Phase 2 study testing Normothermia, Mild hypothermia and Trevo Pro Retriever (Stryker Corp.) in people with Ischemic Stroke and Hypothermia, run by WellStar Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a significant interruption of blood flow to an… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Ischemic Stroke, Hypothermia
- What is being tested?
- Normothermia, Mild hypothermia and Trevo Pro Retriever (Stryker Corp.)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects of any ethnicity and age >/=18 but </= 79 years;
- Symptom onset </=8 hours;
- Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by CT imaging of the brain;
- Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
- Ability to undergo endovascular reperfusion therapy;
- No contraindications to general anesthesia, conscious sedation, or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
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- A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
- Baseline CT scan shows no hemorrhage;
- National Institutes of Health Stroke Scale (NIHSS) 14-29;
- Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy;
- Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities.
- Subject or legally authorized representative must be able to understand and give written informed consent.
Who cannot join
- Females of childbearing potential who are pregnant or not using adequate contraception;
- Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.7 or any active or recent (within 10 to 30 days) hemorrhage;
- History of genetically confirmed hypercoagulable syndrome;
- Any condition that excludes MRI imaging;
- History of dementia, currently on Aricept or Namenda, or other Alzheimer's-like symptoms;
- End stage renal disease on hemodialysis;
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- History of cardiac arrest;
- Presence of an inferior vena cava (IVC) filter;
- Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
- Known allergy to meperidine or buspar;
- Prior neurologic event that would obscure interpretation of the signal and current presenting neurologic deficits;
- Sustained hypertension (systolic blood pressure (SBP) > 185 or diastolic blood pressure (DBP) > 110 refractory to treatment);
- Baseline CT/MRI of head showing evidence of mass effect with mid-line shift, hemorrhage, intracranial tumor, arterial vasculitis or dissection, or bilateral stroke;
- Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit subject cooperation or study compliance;
- Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next 3 months;
- Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
WellStar Kennestone Regional Medical Center
Marietta, Georgia, 30060
About this study
The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients who have undergone hypothermia to those who have not.
Read the detailed description
This study is designed to examine the safety and proof of concept of therapeutic hypothermia prior to conventional revascularization in subjects experiencing acute ischemic stroke by comparing the results to subjects who remain at normal body temperature (normothermic) and proceed directly to reperfusion via conventional reperfusion intervention.
The investigational plan also examines the following outcomes in 85 subjects randomized to either hypothermia or normothermia:
- Regulation of biomarkers indicative of ischemia-reperfusion injury
- Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker
- Incidence of hemorrhagic conversion post reperfusion
- Neurologic function at 90 days post acute ischemic stroke.
The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.
- Conditions
- Ischemic Stroke, Hypothermia
- Being tested
- Normothermia, Mild hypothermia, Trevo Pro Retriever (Stryker Corp.), Zoll Thermogard XP technology with the Quattro catheter
- Keywords
- Acute ischemic stroke, Mild hypothermia, Stroke, Hypothermia, Cerebral infarction, Ischemia, Cerebrovascular disorder, Brain disease, Central nervous system disease, Nervous system disease, Vascular disease, Cardiovascular disease, Brain infarction, Brain ischemia, Pathologic process, Body temperature change, Signs and symptoms
- Medical subject headings
- Ischemic Stroke, Hypothermia, Stroke, Cerebral Infarction, Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormothermiaProcedure or surgery
Also called Clot retrieval, reperfusion
Device: Trevo Pro Retriever (Stryker Corp.)
Mild hypothermiaProcedure or surgery
Also called Therapeutic hypothermia, clot retrieval, reperfusion
Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)
Trevo Pro Retriever (Stryker Corp.)Device
Device: Trevo Pro Retriever (Stryker Corp.)
Zoll Thermogard XP technology with the Quattro catheterDevice
Device: Zoll Thermogard XP technology with the Quattro catheter
| Study group | Role | What they receive |
|---|---|---|
| Normothermia | Active comparator | As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker), after which normothermia will attempt to keep core body temp between 38 and 36.5 degrees centigrade. Receives: Procedure: Normothermia; Device: Trevo Pro Retriever (Stryker Corp.) |
| Mild hypothermia | Experimental | As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker). Subjects will also have a catheter placed in the femoral vein (Zoll Thermogard XP technology with the Quattro catheter) and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours, and then be rewarmed very slowly. Receives: Procedure: Mild hypothermia; Device: Trevo Pro Retriever (Stryker Corp.); Device: Zoll Thermogard XP technology with the Quattro catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhagic Conversion
Acute bleeding into the area of the original stroke based on CT or MRI of the head.
Measured: 48 hours
Secondary outcomes (4)
Hyperintense Acute Reperfusion Marker (HARM)
HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.
Measured: 48 +/- 24 hours
National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a scale from 1-42 to evaluate stroke severity
Measured: Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days
Modified Rankin Scale (mRS)
mRS is a straightforward evaluation of the functional limitations from stroke
Measured: Basline, 48 +/- 24 hours, 90 +/- 15 days
Number of participants with adverse events
Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.
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 posted8 Apr 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: It was decided that it was not feasible to continue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellStar Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Zoll Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Rishi Gupta, MD, Study director, WellStar Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411877
- Sponsor's protocol ID
- RECCLAIM II-S
- Acronym
- RECCLAIM-II
- Status last verified
- Feb 2016
- First submitted
- 25 Mar 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REperfusion With Cooling in CerebraL Acute IscheMia II
- ClinicalTrials.gov ID
- NCT02411877
- Acronym / sponsor ID
- RECCLAIM-II / RECCLAIM II-S
- Conditions
- Ischemic Stroke, Hypothermia
- Keywords
- Acute ischemic stroke, Mild hypothermia, Stroke, Hypothermia, Cerebral infarction, Ischemia, Cerebrovascular disorder, Brain disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was decided that it was not feasible to continue this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- WellStar Health SystemUniversity, hospital or other
- Collaborators
- Zoll Medical Corporation
- Study start
- Feb 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
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 study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients who have undergone hypothermia to those who have not.
Detailed description
This study is designed to examine the safety and proof of concept of therapeutic hypothermia prior to conventional revascularization in subjects experiencing acute ischemic stroke by comparing the results to subjects who remain at normal body temperature (normothermic) and proceed directly to reperfusion via conventional reperfusion intervention.
The investigational plan also examines the following outcomes in 85 subjects randomized to either hypothermia or normothermia:
- Regulation of biomarkers indicative of ischemia-reperfusion injury
- Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker
- Incidence of hemorrhagic conversion post reperfusion
- Neurologic function at 90 days post acute ischemic stroke.
The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normothermia | Active comparator | Procedure: Normothermia, Device: Trevo Pro Retriever (Stryker Corp.)As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker), after which normothermia will attempt to keep core body temp between 38 and 36.5 degrees centigrade. |
| Mild hypothermia | Experimental | Procedure: Mild hypothermia, Device: Trevo Pro Retriever (Stryker Corp.), Device: Zoll Thermogard XP technology with the Quattro catheterAs part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker). Subjects will also have a catheter placed in the femoral vein (Zoll Thermogard XP technology with the Quattro catheter) and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours, and then be rewarmed very slowly. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects of any ethnicity and age >/=18 but </= 79 years;
- Symptom onset </=8 hours;
- Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by CT imaging of the brain;
- Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
- Ability to undergo endovascular reperfusion therapy;
Key exclusion criteria (16 listed)
- Females of childbearing potential who are pregnant or not using adequate contraception;
- Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.7 or any active or recent (within 10 to 30 days) hemorrhage;
- History of genetically confirmed hypercoagulable syndrome;
- Any condition that excludes MRI imaging;
- History of dementia, currently on Aricept or Namenda, or other Alzheimer's-like symptoms;
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 |
|---|---|---|
| NormothermiaAlso: Clot retrieval, reperfusionDevice: Trevo Pro Retriever (Stryker Corp.) | Procedure or surgery | Normothermia |
| Mild hypothermiaAlso: Therapeutic hypothermia, clot retrieval, reperfusionDevice: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.) | Procedure or surgery | Mild hypothermia |
| Trevo Pro Retriever (Stryker Corp.)Device: Trevo Pro Retriever (Stryker Corp.) | Device | Mild hypothermia, Normothermia |
| Zoll Thermogard XP technology with the Quattro catheterDevice: Zoll Thermogard XP technology with the Quattro catheter | Device | Mild hypothermia |
Primary outcome
Hemorrhagic Conversion
Time frame: 48 hours
Acute bleeding into the area of the original stroke based on CT or MRI of the head.
4 secondary outcomes
Hyperintense Acute Reperfusion Marker (HARM)
Time frame: 48 +/- 24 hours
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days
Modified Rankin Scale (mRS)
Time frame: Basline, 48 +/- 24 hours, 90 +/- 15 days
Number of participants with adverse events
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
Rishi Gupta, MD study director
WellStar Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normothermia, Mild hypothermia and Trevo Pro Retriever (Stryker Corp.) in people with Ischemic Stroke and Hypothermia, run by WellStar Health System at 1 site in United States.
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 12 inclusion and 16 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: withdrawn, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hemorrhagic Conversion (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2016.