Levels of Inflammatory Markers in the Treatment of Stroke—An SPS3 Ancillary Study "LIMITS"

Completed

Phase N/A Results N/A

Trial Description

The goals of this trial are to determine the prognostic significance of an elevated level of inflammatory blood markers in people who have experienced small subcortical strokes and who are enrolled in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial.

Detailed Description

Inflammation is increasingly recognized as playing a central role in atherosclerosis and coronary artery disease. And, peripheral blood markers of inflammation have been associated with incident and recurrent cardiac events. The relationship of these risk markers—which have the potential to be modified—to prognosis after ischemic stroke is less clear.
The Levels of Inflammatory Markers in the Treatment of Stroke (LIMITS) study will address questions about the role of inflammatory markers in secondary stroke prevention in a cost-effective manner using the well-established framework of the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. The SPS3 trial is an ongoing Phase 3, multicenter secondary stroke prevention trial that focuses on preventing stroke recurrence in people with small vessel ischemic stroke, or lacunes.
The overall purpose of the LIMITS study is to determine if serum levels of inflammatory markers—such as hsCRP, serum amyloid A (SAA), CD40 ligand (CD40L), and monocyte chemoattractant protein-1 (MCP-1)—predict recurrent stroke and other vascular events among people with a history of small artery ischemic stroke. The project will also determine if these markers predict which people will respond best to dual antiplatelet therapy with clopidogrel and aspirin.
The specific aims of LIMITS are to determine if hsCRP, SAA, CD40L, and MCP-1 levels are independent risk factors for recurrent ischemic stroke, and for recurrent ischemic stroke, myocardial infarction, and death in participants in the SPS3 trial after adjusting for demographic and traditional stroke risk factors, and other treatments, using a prospective cohort of people with small subcortical strokes from the SPS3 trial. LIMITS also aims to compare the efficacy of dual versus single antiplatelet therapy among participant groups with and without elevated baseline inflammatory marker levels for the outcome of a.) recurrent stroke, and b.) recurrent ischemic stroke, myocardial infarction, or death.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Patients with a symptomatic small vessel stroke within prior 6 month and enrolled in SPS3

Patient Involvement

Patient must be enrolled in Secondary Prevention of Small Subcortical strokes (SPS3)trial and have blood collected at baseline and at their one-year follow-up visits.

Outcomes

Type Measure Time Frame Safety Issue
Primary Ischemic stroke, myocardial infarction, death.
Secondary Major Cognitive Decline.
Primary Percentage of participants with recurrent stroke Up to 5 years
Secondary Percentage of participants developing major cognitive decline Up to 5 years

Biospecimen Retention:Samples Without DNA - blood serum (ancillary study)

Sponsors