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Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study (LIMITS)

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ClinicalTrials.gov Identifier: NCT00579306
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Mitchell S Elkind, Columbia University

Tracking Information
First Submitted Date December 20, 2007
First Posted Date December 24, 2007
Last Update Posted Date July 24, 2017
Actual Study Start Date June 2005
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2017)
Percentage of participants with recurrent stroke [ Time Frame: Up to 5 years ]
Participants with recurrence of any stroke during follow-up, including ischemic (an acute localized ischemic lesion in the brain not attributable to central nervous system infection, tumor, demyelinating, or degenerative neurologic diseases due to an occlusive vascular disorder) and hemorrhagic (acute extravasation of blood into the parenchyma of the central nervous system or subarachnoid space).
Original Primary Outcome Measures
 (submitted: December 20, 2007)
Ischemic stroke, myocardial infarction, death. [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures
 (submitted: July 20, 2017)
Percentage of participants developing major cognitive decline [ Time Frame: Up to 5 years ]
Documentation of a major cognitive decline during follow-up. This is a clinical decline in cognitive function manifested by functional deterioration/behavioral changes that are not associated with a clinical stroke event. Criteria: Both A and B must be met: A) A drop in the Cognitive Abilities Screening Instrument (CASI) score of > 10 points since study entry and sustained on repeat testing in approximately one month B) Associated behavioral changes and/or function
Original Secondary Outcome Measures
 (submitted: December 20, 2007)
Major Cognitive Decline. [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study
Official Title Levels of Inflammatory Markers in the Treatment of Stroke
Brief Summary The goals of this trial are to determine the prognostic significance of an elevated level of inflammatory blood markers in people who have experienced small subcortical strokes and who are enrolled in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial.
Detailed Description

Inflammation is increasingly recognized as playing a central role in atherosclerosis and coronary artery disease. And, peripheral blood markers of inflammation have been associated with incident and recurrent cardiac events. The relationship of these risk markers-which have the potential to be modified-to prognosis after ischemic stroke is less clear.

The Levels of Inflammatory Markers in the Treatment of Stroke (LIMITS) study will address questions about the role of inflammatory markers in secondary stroke prevention in a cost-effective manner using the well-established framework of the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. The SPS3 trial is an ongoing Phase 3, multicenter secondary stroke prevention trial that focuses on preventing stroke recurrence in people with small vessel ischemic stroke, or lacunes.

The overall purpose of the LIMITS study is to determine if serum levels of inflammatory markers-such as hsCRP, serum amyloid A (SAA), CD40 ligand (CD40L), and monocyte chemoattractant protein-1 (MCP-1)-predict recurrent stroke and other vascular events among people with a history of small artery ischemic stroke. The project will also determine if these markers predict which people will respond best to dual antiplatelet therapy with clopidogrel and aspirin.

The specific aims of LIMITS are to determine if hsCRP, SAA, CD40L, and MCP-1 levels are independent risk factors for recurrent ischemic stroke, and for recurrent ischemic stroke, myocardial infarction, and death in participants in the SPS3 trial after adjusting for demographic and traditional stroke risk factors, and other treatments, using a prospective cohort of people with small subcortical strokes from the SPS3 trial. LIMITS also aims to compare the efficacy of dual versus single antiplatelet therapy among participant groups with and without elevated baseline inflammatory marker levels for the outcome of a.) recurrent stroke, and b.) recurrent ischemic stroke, myocardial infarction, or death.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood serum (ancillary study)
Sampling Method Probability Sample
Study Population Patients with a symptomatic small vessel stroke within prior 6 month and enrolled in SPS3
Condition
  • Hypertension
  • Stroke
Intervention Not Provided
Study Groups/Cohorts SPS3 patient cohort
All SPS3 patients who participate in Baseline and 1-Year F/U blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 5, 2016)
1244
Original Estimated Enrollment
 (submitted: December 20, 2007)
1440
Actual Study Completion Date July 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient must be randomized within 6 months of qualifying small subcortical stroke (S3) or subcortical TIA
  • One of the following lacunar syndromes: PMH; pure sensory stroke; sensorimotor stroke; ataxic hemiparesis; dysarthria; hemiballism; PMH with facial sparing, horizontal gaze palsy, contralateral III palsy, contralateral VI palsy; Ataxia with contralateral III palsy; pure dysarthria
  • Absence of cortical dysfunction (aphasia, apraxia, agnosia)
  • No ipsilateral cervical carotid stenosis (>= 50%) if S3 is hemispheric
  • No major-risk cardioembolic sources requiring anti-coagulation
  • MRI evidence of S3 that is >=2.0 cm in diameter if DWI/bright lesion on FLAIR/T2 or <=1.5cm hypointense lesion on FLAIR/T1, corresponding to the qualifying event (required for all brainstem events) OR multiple S3 in cerebral hemispheres of <=1.5cm hypointense lesions on FLAIR/T1 AND absence of cortical stroke and large subcortical stroke.

Exclusion Criteria:

  • Disabling stroke (Ranking Scale >= 4)
  • Prior hemorrhagic stroke
  • Age <30 years
  • High risk of bleeding (recurrent GI or GU bleeding, active peptic ulcer disease, etc)
  • Need for long-term use of anticoagulants or other antiplatelet agents.
  • Prior cortical or retinal stroke / TIA
  • Prior ipsilateral carotid endarterectomy if hemispheric S3
  • Impaired renal function: GFR<40 cc/min
  • Intolerance/contraindication to aspirin or clopidogrel
  • Adjusted Folstein MMSE <24
  • Medical contraindication to MRI
  • Pregnancy or child-bearing potential without contraception
  • Other specific causes of stroke (e.g. dissection, vasculitis, drug abuse)
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Chile,   Ecuador,   Mexico,   Peru,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00579306
Other Study ID Numbers AAAB1202
R01NS050724 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Mitchell S Elkind, Columbia University
Original Responsible Party Mitchell S.V. Elkind, M.D., M.S., F.A.A.N., Principal Investigator/Associate Professor of Neurology, Columbia University
Current Study Sponsor Columbia University
Original Study Sponsor Same as current
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Mitchell S. Elkind, MD, MS, FAAN Columbia University
Principal Investigator: Oscar Benavente, MD UTHSC San Antonio (SPS3 Principal Investigator)
Principal Investigator: Robert Hart, MD UTHSC San Antonio (SPS3 Principal Investigator)
PRS Account Columbia University
Verification Date July 2017