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Systolic blood pressure level and risk of intracerebral hemorrhage.
Proposal
1100
Title of Proposed Research
Systolic blood pressure level and risk of intracerebral hemorrhage.
Lead Researcher
Jacoba P Greving
Affiliation
Julius Center for Health Sciences and Primary Care
UMC Utrecht
Funding Source
None
Potential Conflicts of Interest
None
Data Sharing Agreement Date
13 January 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
[{ "PostingID": 1970, "Title": "BI-9.159", "Description": "PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
Medicine: dipyridamole + acetylsalicylic acid, Condition: Stroke, Phase: 4, Clinical Study ID: 9.159, Sponsor: Boehringer Ingelheim" }]
Statistical Analysis Plan
Patients in the PROFESS trial will be divided into 5 prespecified groups according to their mean SBP level: very low–normal (<120 mm Hg), low-normal (120-<130 mm Hg), high-normal (130-<140mmHg), high (140-<150 mm Hg), and very high (=150 mmHg). Systolic BP is chosen because of its relatively stronger relationship with vascular risk, the J-curve phenomenon, and to be consistent with data from other recently published studies on this topic. The SBP groups are chosen to reflect levels mentioned in guideline recommendations, for consistency with other studies, and practical considerations in routine clinical settings. Blood pressure measurements from post-baseline clinic visits before the first occurrence of intracerebral hemorrhage will be used to determine the mean follow-up BP. For patients without post baseline SBP measurements prior to the event, we will use their baseline values. The group with mean SBP within the high-normal range will be the reference group.
To investigate the association between of SBP levels on risk of intracerebral hemorrhage, we will perform univariable and multivariable Cox regression analyses.
Publication Citation
http://www.neurology.org/content/88/2/177.full.html
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