Lead Investigator: Adam de Havenon, Yale University
Title of Proposal Research: Baseline Stroke Severity in Secondary Prevention Trials
Vivli Data Request: 8611
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
An ischemic stroke happens when a blockage cuts off the blood supply to part of your brain, killing brain cells. Damage to brain cells can affect how the body works. It can also change how you think and feel. Trials of medications to prevent a recurrent (second) ischemic stroke have historically not included participants who had disability from their first stroke. This may have influenced the results of these trials because a lot of stroke survivors have disability. The exception is the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial, which did include participants with disability. We are conducting an analysis of PRoFESS to better understand the possible benefits of including participants with disability in clinical trials, which could have a major impact on future trials and lead to more inclusive studies. We selected PRoFESS because it is a large cohort of patients with stroke and has a a large number of recurrent events during several years of follow-up. In the proposed project, we will report the number and rate of recurrent stroke in different categories of disability at the beginning of the trial. We will also examine if the level of baseline disability had an impact on how long participants stayed in the trial and if it influenced the effectiveness of the medications used in the trial. This study could have major public health impact by leading to more inclusive stroke prevention trials that include participants with disability at baseline.
Requested Studies:
PRoFESS – Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
Data Contributor: Boehringer Ingelheim
Study ID: NCT00153062
Sponsor ID: 9.159