“SPS3,” Secondary Prevention of Small Subcortical Strokes Trial   Sponsor     National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)   Berman Center Site Investigators     Principal Investigator: David Anderson, MD, Chair, Neurology Service, HCMC & Department of Neurology, University of Minnesota Co-Investigators: Scott Bundlie, MD, Neurology, HCMC Richard Grimm, MD, MPH, PhD, Berman Center for Outcomes & Clinical Research   Berman Center Site Coordinator     Donna Brauer, PhD, RN 612-347-4420   Description     The goal of this study is to identify the optimal combinations of antiplatelet therapy (aspirin and clopidogrel vs. aspirin alone) and blood pressure control (intensive vs. less intensive control) for preventing recurrent strokes and cognitive decline in patients who have experienced a small sub-cortical stroke.   Role of the Berman Center     The Berman Center maintains contact with neurologists at five local, referring hospitals, to identify prospective participants. If the patient is interested in participating, and chart abstraction shows that they meet basic eligibility criteria, the Berman Center conducts an additional on-site screening visit and if eligible, randomizes the patient into one of the four treatment groups. The Berman Center follows all patients for aggressive blood pressure monitoring and control, with required visits at 2 weeks, 4 weeks, 8 weeks and then every 3 months for the next two years. The research nurse/study coordinator may see the participant more frequently if blood pressure is not under targeted control. The Berman Center submits all study data to the coordinating center in San Antonio.   Basic enrollment information     Male and female participants must be at least 40 years of age and have had at least one clinical symptom of a small subcortical stroke (also called lacunar stroke) within the last three months.   Abstract     This multi-center study will recruit 2500 participants (20 percent of whom will be Hispanic Americans) over two years. The study is a 2x2 factorial design, in which one factor is antiplatelet therapy (aspirin and clopidogrel vs. aspirin and placebo), and the other is level of blood pressure control (SBP < 130 mmHg vs. usual recommendation of SBP 130-149). The antiplatelet therapy arm of the trial is double-blinded. Controlling blood pressure to target uses any and all available medications, all of which are open-label. However, outcome assessments are made by neurologists blinded to treatment assignment. Participants are treated and followed for two years after randomization. The major outcomes are stroke symptoms, major vascular bleeding, and cognitive functioning.