SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The SPS3 study consists of two randomized, multi-center clinical trials. The objectives of this study are to define efficacious therapies for prevention of stroke recurrence and cognitive decline in patients with symptomatic small subcortical stroke. The first study is a Phase III randomized 2X2 controlled trial. Patients with a symptomatic S3 within prior 3 months will be randomized to aspirin vs. aspirin + clopidogrel. Efficacy will be determined by recurrent stroke during a mean follow-up of 3 years. The guiding hypotheses to be tested in the SPS3 hypertension trial are that "intensive" control of blood pressure (target systolic BP of less than 130 mmHg) will result in fewer recurrent strokes, less cognitive decline, and a decrease in other major vascular events with no adverse impact on quality of life compared to "usual" management (target systolic BP of 130-149 mm Hg). The goal is to compare the effects of two levels of BP control, and not to compare the use of specific antihypertensive agents. Management of hypertension in SPS3 to achieve the assigned targets will be based on "best practice" recommendations from national guidelines. The blood pressure component of the trial will be open-label, using the so-called PROBE (Prospective Randomized, Open-label with Blinded Event assessment) design widely used in multicenter hypertension trials. Enrollment will be over three years, with an additional 1.5 years of follow up (mean follow up of three years). A battery of cognitive tests will be performed at entry, yearly thereafter, and at study end. Brain MRIs are required at entry to document eligibility and at the time of subsequent TIA/stroke/major cognitive decline. Ambulatory blood pressure monitoring will be performed after target levels of blood pressures are achieved.