Acute Ischemic StrokePhase 3SHINENCT01369069

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

A Phase 3 study testing IV insulin to maintain target glucose concentration of 80-130 mg/dL in people with Acute Ischemic Stroke and Diabetes, run by University of Virginia at 70 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Ischemic Stroke, Diabetes, Hyperglycemia
What is being tested?: IV insulin to maintain target glucose concentration of 80-130 mg/dL
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,151 participants
Where: 70 sitesUnited States
Study dates: Apr 2012to 19 Nov 2018
Phase: Phase 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older
Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).
Randomization must be within 12 hours after stroke symptom onset and treatment is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.
Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus
Baseline NIHSS score of 3-22
Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22.
Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines.

Who cannot join

Known history of type 1 diabetes mellitus
Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
Pregnant or breast-feeding at the time of study entry
Other serious conditions that make the patient unlikely to survive 90 days
Inability to follow the protocol or return for the 90 day follow up
Renal dialysis (including hemo or peritoneal dialysis)

Trial locations and contacts

70 sites in 1 country.

City, postcode or hospital

70 sites in 1 country

United States70 sites

Abington Memorial Hospital
Abington, Pennsylvania, 19001
Summa Akron City Hospital
Akron, Ohio, 44307
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital - Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Grady Memorial Hospital
Atlanta, Georgia, 30322
Augusta University Medical Center
Augusta, Georgia, 30912
Dell Seton Medical Center at UT
Austin, Texas, 78701
Seton Medical Center
Austin, Texas, 78705
University of Maryland Medical Center
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kings County Hospital
Brooklyn, New York, 11203
SUNY Downstate University Hospital of Brooklyn
Brooklyn, New York, 11203
Buffalo General Medical Center
Buffalo, New York, 14210
University of Virginia
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45221
Wexner Medical Center
Columbus, Ohio, 43210
UT Southwestern-Parkland Memorial Hospital
Dallas, Texas, 75390
UT Southwestern-Zale Lipshy University Hospital
Dallas, Texas, 75390
Miami Valley Hospital
Dayton, Ohio, 45409
Detroit Receiving Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Sinai-Grace Hospital
Detroit, Michigan, 48235
JFK Medical Center
Edison, New Jersey, 08818
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Valley Baptist Medical Center
Harlingen, Texas, 78552
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Memorial Herman Hospital
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky
Lexington, Kentucky, 40506
Long Beach Memorial Medical Center
Long Beach, California, 90806
Ronald Regan Medical Center
Los Angeles, California, 90095
Jackson Memorial Hospital
Miami, Florida, 33136
Froedtert Memorial Hospital
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506
St. Thomas Neuroscience Research Institute
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
The Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical Center
New York, New York, 10065
Maimonides Medical Center
New York, New York, 11219
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
UPMC - Mercy
Pittsburgh, Pennsylvania, 15219
Virginia Commonwealth University
Richmond, Virginia, 23298
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
San Francisco General Hospital
San Francisco, California, 94110
California Pacific Medical Center - Davies Campus
San Francisco, California, 94114
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94114
UCSF Medical Center
San Francisco, California, 94117
Harborview Medical Center
Seattle, Washington, 98104
Stanford University Medical Center
Stanford, California, 94305
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451
William Beaumont Hospital-Troy
Troy, Michigan, 48085
University of Arizona Medical Center - South Campus
Tucson, Arizona, 85713
University of Arizona
Tucson, Arizona, 85724
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
WellSpan York Hospital
York, Pennsylvania, 17403

Other trials in United States

About this study

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.

Read the detailed description

Eligible subjects must be randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and glucose concentrations of 150 mg/dL or higher on initial evaluation. The enrolling sites include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study evaluates the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL.

Conditions: Acute Ischemic Stroke, Diabetes, Hyperglycemia
Being tested: IV insulin to maintain target glucose concentration of 80-130 mg/dL, Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
Keywords: stroke, diabetes, hyperglycemia
Medical subject headings: Ischemic Stroke, Diabetes Mellitus, Hyperglycemia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV insulin to maintain target glucose concentration of 80-130 mg/dLDrug
Also called Continuous intravenous insulin
Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dLDrug
Also called Sliding scale insulin
Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Study groups in NCT01369069
Study group	Role	What they receive
IV insulin drip with target glucose 80 mg/dL - 130 mg/dL	Experimental	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. Receives: Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL
Sub Q insulin to keep glucose less than 180 mg/dL	Active comparator	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Receives: Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.
Measured: 90 days (-14/+30 days)
Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)
Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.
Measured: 72 hours

Secondary outcomes (3)

Number of Participants With a Favorable NIHSS
The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization.
Measured: Follow up (Max 164 days)
Number of Participants With a Favorable Barthel Index
Favorable outcomes for the Barthel Index was defined as a score of 95-100 on the BI at 90 days post randomization. Barthel - Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. Scores range from 0-100 with higher scores indicating greater ability to perform activities of daily living.
Measured: Follow up (Max 164 days)
Stroke Specific Quality of Life (SSQOL)
Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life
Measured: Follow up (Max 164 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201219 Nov 2018

First posted8 Jun 2011 (estimated)
Study startApr 2012
Primary completion19 Nov 2018
Study completion19 Nov 2018

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 (6)Papers the sponsor has linked to this study.
Other trials for Acute 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 1,151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369069
Sponsor's protocol ID: 15959
Other IDs: U01NS069498
Acronym: SHINE
Status last verified: Dec 2019
First submitted: 6 Jun 2011
Last updated: 23 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.
PubMed 31334795
Southerland AM, Mayer SA, Chiota-McCollum NA, Bolte AC, Pauls Q, Pettigrew LC, Bleck TP, Conaway M, Johnston KC. Glucose Control and Risk of Symptomatic Intracerebral Hemorrhage Following Thrombolysis for Acute Ischemic Stroke: A SHINE Trial Analysis. Neurology. 2024 May 14;102(9):e209323. doi: 10.1212/WNL.0000000000209323. Epub 2024 Apr 16.
PubMed 38626363
Arteaga DF, Ulep R, Kumar KK, Southerland AM, Conaway MR, Faber J, Wintermark M, Joyner D, Sharashidze V, Hirsch K, Giurgiutiu DV, Hannawi Y, Aziz Y, Shutter L, Visweswaran A, Williams A, Williams K, Gunter S, Haughey HM, Bruno A, Johnston KC, Patel VN; SHINE Trial Investigators. Collateral status, hyperglycemia, and functional outcome after acute ischemic stroke. BMC Neurol. 2022 Nov 4;22(1):408. doi: 10.1186/s12883-022-02943-4.
PubMed 36333676
Connor JT, Broglio KR, Durkalski V, Meurer WJ, Johnston KC. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study. Trials. 2015 Mar 4;16:72. doi: 10.1186/s13063-015-0574-8.
PubMed 25885963
Garofolo KM, Yeatts SD, Ramakrishnan V, Jauch EC, Johnston KC, Durkalski VL. The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomes. Trials. 2013 Apr 11;14:98. doi: 10.1186/1745-6215-14-98.
PubMed 24499406
Bruno A, Durkalski VL, Hall CE, Juneja R, Barsan WG, Janis S, Meurer WJ, Fansler A, Johnston KC; SHINE investigators. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial protocol: a randomized, blinded, efficacy trial of standard vs. intensive hyperglycemia management in acute stroke. Int J Stroke. 2014 Feb;9(2):246-51. doi: 10.1111/ijs.12045. Epub 2013 Mar 19.
PubMed 23506245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Acute Ischemic Stroke AIS

All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
ClinicalTrials.gov ID: NCT01369069
Acronym / sponsor ID: SHINE / 15959
Conditions: Acute Ischemic Stroke, Diabetes, Hyperglycemia
Keywords: stroke, diabetes, hyperglycemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,151 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Neurological Emergencies Treatment Trials Network (NETT), Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Apr 2012 (actual)
Primary completion: 19 Nov 2018 (actual)
Study completion: 19 Nov 2018 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Posted 16 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IV insulin drip with target glucose 80 mg/dL - 130 mg/dL	Experimental	Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dLThe intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.
Sub Q insulin to keep glucose less than 180 mg/dL	Active comparator	Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dLThis standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18 years or older
Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).
Randomization must be within 12 hours after stroke symptom onset and treatment is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.
Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus
Baseline NIHSS score of 3-22

Key exclusion criteria (7 listed)

Known history of type 1 diabetes mellitus
Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
Pregnant or breast-feeding at the time of study entry
Other serious conditions that make the patient unlikely to survive 90 days

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
IV insulin to maintain target glucose concentration of 80-130 mg/dLAlso: Continuous intravenous insulinIntervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.	Drug	IV insulin drip with target glucose 80 mg/dL - 130 mg/dL
Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dLAlso: Sliding scale insulinSliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.	Drug	Sub Q insulin to keep glucose less than 180 mg/dL

Primary outcome

Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
Time frame: 90 days (-14/+30 days)
Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.
Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)
Time frame: 72 hours
Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.

3 secondary outcomes

Number of Participants With a Favorable NIHSS
Time frame: Follow up (Max 164 days)
Number of Participants With a Favorable Barthel Index
Time frame: Follow up (Max 164 days)
Stroke Specific Quality of Life (SSQOL)
Time frame: Follow up (Max 164 days)

Results and safety

Results posted to the registry on 16 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	581	564
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	570	554

Primary outcome: Number of Participants With a Favorable Modified Rankin Scale (Yes/No)

Time frame: 90 days (-14/+30 days). Count of participants. Unit: Participants

Measure	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL n = 581	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL n = 570
Value	119	123

IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Risk Ratio (RR): 0.97 (95% CI 0.87 to 1.08), p = 0.55, Regression, Logistic

Primary outcome: Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)

Time frame: 72 hours. Count of participants. Unit: Participants

Measure	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL n = 581	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL n = 570
Value	15	0

IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL vs Sub Q Insulin to Keep Glucose Less Than 180 mg/dL: Risk Difference (RD): 2.58 (95% CI 1.29 to 3.87), p <0.001, Fisher Exact

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events were assessed and reported through the treatment period (up to 72 hours). Serious adverse events were reported throughout the study period (randomization through end of study; end of study was 90 days post randomization or earlier if a participant died or withdrew consent).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	209 of 581 (36%)	384 of 581 (66.1%)	54 of 581
Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	198 of 570 (34.7%)	134 of 570 (23.5%)	65 of 570

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31334795Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.
Derived from this study: PubMed 38626363Southerland AM, Mayer SA, Chiota-McCollum NA, Bolte AC, Pauls Q, Pettigrew LC, Bleck TP, Conaway M, Johnston KC. Glucose Control and Risk of Symptomatic Intracerebral Hemorrhage Following Thrombolysis for Acute Ischemic Stroke: A SHINE Trial Analysis. Neurology. 2024 May 14;102(9):e209323. doi: 10.1212/WNL.0000000000209323. Epub 2024 Apr 16.
Derived from this study: PubMed 36333676Arteaga DF, Ulep R, Kumar KK, Southerland AM, Conaway MR, Faber J, Wintermark M, Joyner D, Sharashidze V, Hirsch K, Giurgiutiu DV, Hannawi Y, Aziz Y, Shutter L, Visweswaran A, Williams A, Williams K, Gunter S, Haughey HM, Bruno A, Johnston KC, Patel VN; SHINE Trial Investigators. Collateral status, hyperglycemia, and functional outcome after acute ischemic stroke. BMC Neurol. 2022 Nov 4;22(1):408. doi: 10.1186/s12883-022-02943-4.
Derived from this study: PubMed 25885963Connor JT, Broglio KR, Durkalski V, Meurer WJ, Johnston KC. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study. Trials. 2015 Mar 4;16:72. doi: 10.1186/s13063-015-0574-8.
Derived from this study: PubMed 24499406Garofolo KM, Yeatts SD, Ramakrishnan V, Jauch EC, Johnston KC, Durkalski VL. The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomes. Trials. 2013 Apr 11;14:98. doi: 10.1186/1745-6215-14-98.
Derived from this study: PubMed 23506245Bruno A, Durkalski VL, Hall CE, Juneja R, Barsan WG, Janis S, Meurer WJ, Fansler A, Johnston KC; SHINE investigators. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial protocol: a randomized, blinded, efficacy trial of standard vs. intensive hyperglycemia management in acute stroke. Int J Stroke. 2014 Feb;9(2):246-51. doi: 10.1111/ijs.12045. Epub 2013 Mar 19.
General information of trialLink provided by the sponsor.

Related trials for Acute Ischemic Stroke

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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.

Karen C Johnston, MD, MSc study chair

University of Virginia

Christiana Hall, MD, MS principal investigator

UT Southwestern

Askiel Bruno, MD, MS principal investigator

Augusta University

70 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites 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 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 16 Dec 2019). 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?

Number of Participants With a Favorable Modified Rankin Scale (Yes/No) (time frame: 90 days (-14/+30 days)). The study lists 2 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 NCT01369069, which also lists 6 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 23 Dec 2019.