The Secondary Prevention of Small Subcortical Strokes (SPS3) study

Area of Science:

• Neurology
• Cardiovascular Medicine
• Clinical Trials

Background:

• Small subcortical strokes (lacunar strokes) account for over 25% of brain infarcts.
• Underlying vasculopathy is a primary cause of vascular cognitive impairment.
• Optimal strategies for secondary stroke prevention and cognitive decline in these patients remain undefined.

Purpose of the Study:

• To define effective strategies for reducing stroke recurrence in patients with small subcortical strokes.
• To identify methods for preventing cognitive decline following lacunar infarcts.
• To evaluate interventions aimed at minimizing major vascular events in this population.

Main Methods:

• A randomized, multicenter clinical trial (Secondary Prevention of Small Subcortical Strokes) involving 3000 patients.
• A 2x2 factorial design testing dual antiplatelet therapy (aspirin plus clopidogrel) versus aspirin alone, and intensive (<130 mmHg) versus usual (130-149 mmHg) systolic blood pressure targets.
• Central adjudication of outcomes by blinded assessors over an average four-year follow-up period.

Main Results:

• The trial is designed to analyze time to recurrent stroke (ischemic or hemorrhagic) as the primary outcome for each intervention separately.
• Secondary outcomes include the rate of cognitive decline and major vascular events.
• Results will be based on central adjudication of primary and secondary outcomes by assessors unaware of treatment assignment.

Conclusions:

• The Secondary Prevention of Small Subcortical Strokes trial will provide critical insights into managing lacunar infarcts, likely caused by small vessel disease.
• Testing dual antiplatelet therapy and intensive blood pressure control will address key clinical questions.
• Findings are expected to guide the management of millions affected by this common vascular disorder.