Nearly two million survivors of small subcortical strokes (S3, a.k.a. lacunar infarcts) in the U.S. are at high risk for recurrent stroke and for developing vascular dementia. S3s are one of the most common stroke subtypes in Hispanics.
The aims of the Secondary Prevention of Small Subcortical Strokes (SPSS) trial are to define efficacious therapies for prevention of recurrent stroke and cognitive decline in patients with S3. SPSS consists of two randomized, multi-center clinical trials and will enroll 2500 participants (20% of whom will be Hispanic) with symptomatic, MRI-defined S3. Patients are assigned to two interventions in a factorial design: 1. Anti-platelet Intervention: aspirin 325 mg/d vs. aspirin 325 mg/d plus clopidogrel 75 mg/d. 2. Blood Pressure Intervention: 'Usual'hypertension management with systolic blood pressure targets of 130 to 149 mm Hg vs. 'Intensive'hypertension management with systolic blood pressure targets <130 mm Hg. The anti-platelet comparison is double-blinded, while the blood pressure intervention is open-label with blinded assessment of events. Follow-up is every three months for an average of 3 years. The primary aims are: 1. To determine whether combination anti-platelet therapy is more efficacious than aspirin alone for reducing stroke recurrence and cognitive decline. 2. To determine whether 'intensive'blood pressure lowering to a specific target range is superior to 'usual'hypertension management for reducing recurrent strokes and cognitive decline. The original application proposed to enroll 2 patients per month at 35 clinical sites. Randomization started in 2003 and was lower than anticipated. In order to address this problem, we have added additional domestic and international sites, bringing active sites to 63. Recruitment has stabilized at around 40 participants per month over the past year and as of February 1, 2007, 1341 participants were enrolled. At the current rate of enrollment, we anticipate completing recruitment by July 2009, with one additional year of follow-up continuing past that time. No previous randomized trials have focused specifically on secondary prevention after S3, on optimal target levels of blood pressure control after stroke and their relationship to cognitive decline, or on prevention of stroke and dementia specifically in Hispanics. The results of SPSS will likely lead to an important reduction in the burden of stroke and vascular dementia for millions of people with S3, and particularly for Hispanics. The purpose of this application is to request support for continuation and completion of the SPS3 trial given the initial recruitment shortfall. The study design and objectives remain unchanged from the original application.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01NS038529-13S1
Application #
8299293
Study Section
Special Emphasis Panel (ZNS1-SRB-W (26))
Program Officer
Moy, Claudia S
Project Start
1999-09-05
Project End
2012-03-14
Budget Start
2011-02-01
Budget End
2012-03-14
Support Year
13
Fiscal Year
2011
Total Cost
$7,190,991
Indirect Cost
Name
University of British Columbia
Department
Type
DUNS #
251949962
City
Vancouver
State
BC
Country
Canada
Zip Code
V6 1-Z3
Simuni, Tanya; Caspell-Garcia, Chelsea; Coffey, Christopher S et al. (2018) Baseline prevalence and longitudinal evolution of non-motor symptoms in early Parkinson's disease: the PPMI cohort. J Neurol Neurosurg Psychiatry 89:78-88
Magvanjav, Oyunbileg; McDonough, Caitrin W; Gong, Yan et al. (2017) Pharmacogenetic Associations of ?1-Adrenergic Receptor Polymorphisms With Cardiovascular Outcomes in the SPS3 Trial (Secondary Prevention of Small Subcortical Strokes). Stroke 48:1337-1343
Shoamanesh, Ashkan; Pearce, Lesly A; Bazan, Carlos et al. (2017) Microbleeds in the Secondary Prevention of Small Subcortical Strokes Trial: Stroke, mortality, and treatment interactions. Ann Neurol 82:196-207
Odden, Michelle C; McClure, Leslie A; Sawaya, B Peter et al. (2016) Achieved Blood Pressure and Outcomes in the Secondary Prevention of Small Subcortical Strokes Trial. Hypertension 67:63-9
Wilson, Laura K; Pearce, Lesly A; Arauz, Antonio et al. (2016) Morphological classification of penetrating artery pontine infarcts and association with risk factors and prognosis: The SPS3 trial. Int J Stroke 11:412-9
McClure, Leslie A; Szychowski, Jeff M; Benavente, Oscar et al. (2016) A post hoc evaluation of a sample size re-estimation in the Secondary Prevention of Small Subcortical Strokes study. Clin Trials 13:537-44
Boehme, Amelia K; McClure, Leslie A; Zhang, Yu et al. (2016) Inflammatory Markers and Outcomes After Lacunar Stroke: Levels of Inflammatory Markers in Treatment of Stroke Study. Stroke 47:659-67
Field, Thalia S; McClure, Leslie A; White, Carole L et al. (2015) Should Blood Pressure Targets After Lacunar Stroke Vary by Body Size? The SPS3 Trial. Am J Hypertens 28:756-64
Dhamoon, Mandip S; McClure, Leslie A; White, Carole L et al. (2015) Long-term disability after lacunar stroke: secondary prevention of small subcortical strokes. Neurology 84:1002-8
Palacio, Santiago; Hart, Robert G; Pearce, Lesly A et al. (2015) Effect of addition of clopidogrel to aspirin on stroke incidence: Meta-analysis of randomized trials. Int J Stroke 10:686-91

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