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

Completed

Conditions studied: Hypertension, Stroke

In brief

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.

Key facts

Study ID

NCT00579306

Run by

Columbia University

People needed

1244

Starts

2005-06-01

Expected to finish

2012-07-01

Last updated by the study team

2017-07-24

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• University of Arizona Collage of Medicine — Tucson, Arizona, United States
• University of California, San Diego Medical Center — La Jolla, California, United States
• Sutter Neuroscience Institute — Sacramento, California, United States
• Melbourne Internal Medicine Associates — Melbourne, Florida, United States
• University of Miami — Miami, Florida, United States
• Mercy Medical Center — Des Moines, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• St. John's Mercy Medical Center — St Louis, Missouri, United States
• Cooper University Hospital, — Camden, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Rochester General Hospital — Rochester, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Helen Hayes Hospital — West Haverstraw, New York, United States
• Wake Forest University Medical Center — Winston-Salem, North Carolina, United States
• University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508 — Cleveland, Ohio, United States
• Metro Health Medical Center — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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