Hypertension Clinical Trial
Official title:
Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
The goal of this study is to learn if combination antiplatelet therapy (aspirin and
clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and
cognitive decline, and if intensive blood pressure control is associated with fewer
recurrent strokes and cognitive decline.
On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to
an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the
investigational anti platelet combination of aspirin + clopidogrel and an interim
statistical analysis that demonstrated futility in the investigational anti platelet arm. It
was recommended that patients be continued on standard care of aspirin mono therapy until
their study close-out visit. Also, recommended the continuation and completion of the plood
pressure arm following the protocol.
Stroke is damage to the brain caused by problems in the blood vessels. Strokes often cause
paralysis, loss of sensation and speech, and other problems. A lacunar or small Subcortical
stroke affects the inner part of the brain causing small "pea sized" areas of damage due to
blockage of small blood vessels within the brain.
This multi-center study will recruit 3000 participants (20 percent of whom will be Hispanic)
to find out if using aspirin and clopidogrel is more effective than using aspirin alone to
prevent recurrent stroke in patients with lacunar stroke confirmed by MRI, and if lowering a
patient's blood pressure below the usual limits will also help prevent recurrent stroke and
maintain thinking ability. Both aspirin and clopidogrel are widely-used for blood clotting
and stroke prevention. Investigators intend to find out if using the drugs together is more
effective than using aspirin alone.
Participants will be randomly assigned to one of 2 types of treatment: either aspirin alone
or the combination of aspirin and clopidogrel. In addition, participants will be assigned to
one of 2 groups of blood pressure control. The difference between the two groups is the
target level of systolic blood pressure—either 130-149 or below 130. The goal of the blood
pressure aspect of this trial is to find out if lowering blood pressure after stroke helps
to prevent recurrent stroke and preserves cognition.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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