What is this Research Study About?
The name of this research study is SPS3 . This stands for
S econdary
P revention of
S mall
S ubcortical
S trokes (SPS3).
A subcortical stroke is a specific type of stroke that occurs when a blood vessel bringing blood deep into the brain becomes blocked. The outer part of the brain is called the cortical area and the deep part (underneath the cortical area) is called the subcortical area. This is why this type of stroke is given this name. These subcortical strokes usually cause ‘pea-sized’ damaged areas. This is due to the blockage of small blood vessels deep in the brain. About 150,000 Americans and about 20,000 Canadians have this type of stroke every year. It is an important health problem.
The main goal of this study is to learn more about preventing another stroke from happening to people who have already had a subcortical stroke. We also want to learn how to prevent the problems with thinking and memory that may happen after a stroke. The National Institutes of Health (NIH) in Washington, D.C., is sponsoring this study. This study is taking place in over 60 different medical centers around the United States, Canada, Latin America, and Europe. In order to answer these important questions, we need 2,500 people to participate in this study.
In this study, we are testing if taking both aspirin and clopidogrel will be more effective in preventing another stroke than just aspirin alone. Aspirin is the standard therapy for this type of stroke. Clopidogrel is another medication that is used to prevent stroke. Both of these medicines affect blood clotting. They are now widely prescribed by doctors for preventing another stroke. Using them together has not before been tested in the specific type of stroke that you have had. All the participants in the study will receive aspirin (325 mg daily). One half of the participants will also receive clopidogrel. The other half will receive a placebo (a pill that contains no medicine). Participants will be assigned by chance (like flipping a coin, called randomization) to receive aspirin and placebo or aspirin and clopidogrel.
In this research study we also want to learn more about controlling blood pressure after a stroke. We need more information about what is the best level of blood pressure after a stroke. Experts in high blood pressure management work with participants and their primary care doctor to bring blood pressure under control. This includes important lifestyle changes to lower blood pressure. Participants may also need medications to lower their blood pressure. If so, they are being be treated using standard medicines, according to accepted guidelines, to lower their blood pressure. Each participant is assigned by chance to one of two groups of blood pressure control. In one group the systolic blood pressure (the top number) is treated to be between 130-149 mm Hg. In the other group, the systolic blood pressure (the top number) is treated to be below 130 mm Hg.
