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Proposal 1100

Title of the Proposed Research

PRoFESS blood pressure variability and risk of intracerebral hemorrhage

Lead Researcher

Dr. Jacoba P Greving


Universitair Medisch Centrum (UMC)

Funding Source


Potential Conflicts of Interest

Potential conflicts of interest will be disclosed when the research is presented and published.

Data Sharing Agreement Date

12 Feb 2015

Lay Summary

Context: Stroke prevention guidelines suggest that larger reductions in systolic blood pressure (SBP) are positively associated with a greater reduction in the risk of recurrent stroke and define an SBP level of less than 120 mm Hg as normal. However, the association of SBP maintained at such levels with risk of intracerebral hemorrhage after a recent ischemic stroke is unclear.

Objective: To assess the association of maintaining low-normal vs. high-normal SBP levels with risk of intracerebral hemorrhage.

Design, Setting, and Patients: Post hoc observational analysis of a multicenter trial involving 20,330 patients (age=50 years) with recent non-cardioembolic ischemic stroke; patients were recruited from 695 centers in 35 countries from September 2003 through July 2006 and followed up for 2.5 years (follow-up ended on February 8, 2008). Patients were categorized based on their mean SBP level: very low–normal (<120 mm Hg), low-normal (120-<130 mm Hg), high-normal (130-<140 mm Hg), high (140-<150 mm Hg), and very high (=150 mm Hg). Main Outcome Measures: The outcome of interest will be the first recurrence of intracerebral hemorrhage.

Study Data Provided

Study 9.159-PRoFESS: Prevention Regimen For Effectively Avoiding Second Strokes

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation