Lead Investigator: James Brorson, The University of Chicago
Title of Proposal Research: Merging data from acute stroke secondary prevention trials for analysis of stroke recurrence risks
Vivli Data Request: 9734
Funding Source: NIH grant R61NS135583 (Brorson), “Kinetic analysis of acute stroke secondary prevention trials: Insights from combined datasets guiding future trial design”.
Potential Conflicts of Interest: James Brorson is supported by National Institutes of Health grants R01AG06263 (Aggarwal) and R61NS135583 (Brorson), and has provided medical-legal consultation and consultation to the National Peer Review Corporation. R61NS135583 supports the present proposal. There is no other overlap or conflict with the present proposal. Any conflicts of interest will be declared in any subsequent publication.
Dr. Giurcanu is supported by National Institutes of Health grants R01 CA236385 (Halpern), R01 CA228036 (Oto), P30 CA014599 (Odunsi), R01 NS107903 (Carroll), R01 ES031615 (Olopade), R18 HS025359 (Prabhakaran), and R61NS135583 (Brorson). Any conflicts of interest will be declared in any subsequent publication.
Dr. Johnson is supported by National Institutes of Health grants HHSN261201800023I / 75N91018D00023 (Ahsan), U54TR002389 (Solway, Ross, and Jacobs), RC2DK133947 (Jabri), and R61NS135583 (Brorson). Any conflicts of interest will be declared in any subsequent publication.
Mr. Gulotta is supported by grants HHSN261201800023I / 75N91018D00023 (Ahsan), UL1 TR002389 (Solway, Ross, and Jacobs), OT2 OD036445 (Ahsan), and R61NS135583 (Brorson). Any conflicts of interest will be declared in any subsequent publication.
Ms. Beniwal is supported by National Institutes of Health grants R18HS027264 (Prabhakaran) and R61NS135583 (Brorson). Any conflicts of interest will be declared in any subsequent publication.
Dr. Siegler is supported by National Institutes of Health grant R61NS135583 (Brorson). Any conflicts of interest will be declared in any subsequent publication.
Summary of the Proposed Research:
Stroke is a common and often devastating condition in which blockage of blood flow to a part of the brain leads to its destruction, with corresponding loss of function, potentially impairing movements of limbs or face, speaking or comprehension, peripheral vision, or coordination and balance. Stroke is the leading cause of long-term disability world-wide, as well as a frequent reason for death. In the United States, some 800,000 persons suffer strokes each year, and over 100,000 die. After an initial minor stroke or transient ischemic attack (TIA), the risk of another stroke is increased, particularly in the initial few days. Recent major clinical trials of immediate preventative treatments after stroke or TIA provide a wealth of information about the timing of recurrence of stroke and of other outcomes of interest, and of clinical features of the subjects that may influence these risks.
We have shown in secondary analyses of data from the POINT, SOCRATES, and THALES trials that the timing of stroke recurrence points to patients being in a temporary vulnerable state following the initial stroke or TIA, with a high risk of another stroke, that transitions over time to a more stabilized state where patients are at lower risk for stroke recurrence. The insights gained from analyses like this can provide important guidance for the appropriate design of clinical trials aiming for secondary stroke prevention, supporting the development of therapeutic interventions. To do so in a statistically reliable fashion requires large numbers of subjects and observations. By merging the data records from the POINT, SOCRATES, and THALES trials into a single large dataset, adequate numbers of observations will be included. Merging the datasets of the separate trials requires harmonizing the data, which means recognizing and correcting for differences in the ways that the individual trials defined or categorized certain patient variables so that the combined data accurately represent the results from each of the trials. Merging these harmonized trial datasets into a single large well-annotated dataset will allow for a powerful analysis of what factors determine stroke recurrence, and what treatments show promise in preventing recurrence.
Requested Studies:
SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES
Data Contributor: AstraZeneca
Study ID: NCT01994720
Sponsor ID: NCT01994720
THALES – Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death (THALES)
Data Contributor: AstraZeneca
Study ID: NCT03354429
Sponsor ID: NCT03354429
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial The data files from this trial have been provided by the National Institute of Neurological Disease and Stroke Data Archive. They are fully anonymized data files. The data set consists of 22 SAS-compatible *.sas7bdat files. The total size is 27.3 MB. The data validity has been established by peer-reviewed publication of primary results and of multiple secondary analyses. These data add to the present project by providing >4000 subject-level data lines with multiple clinical variables describing subject, to be combined with datasets from SOCRATES and THALES trials, similarly studing effects of enhanced antiplatelet regimens on acute secondary stroke prevention.
Data Contributor: I WILL BRING MY OWN
Study ID: NCT00991029
Sponsor ID: NCT00991029