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Original article
Taking care of volunteers in a stroke trial: a new assisted-management strategy
  1. Amber C Stuart1,
  2. Jason J Sico1,2,3,
  3. Catherine M Viscoli1,
  4. Ashis H Tayal4,5,
  5. Silvio E Inzucchi1,
  6. Gary A Ford6,
  7. Karen L Furie7,
  8. Robert Cote8,
  9. J David Spence9,
  10. David Tanne10,
  11. Walter N Kernan1
  12. on behalf of the IRIS Trial Investigators
  1. 1Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
  2. 2Department of Neurology, Yale University School of Medicine, New Haven, Connecticut, USA
  3. 3Department of Neurology Service, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, USA
  4. 4Neuroscience Institute, Allegheny Health Network, Pittsburgh, Pennsylvania, USA
  5. 5Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, USA
  6. 6Division of Medical Sciences, Oxford University, Oxford, UK
  7. 7The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA
  8. 8Department of Neurology, Neurosurgery and Medicine, McGill University, Montreal, Quebec, Canada
  9. 9University of Western Ontario, London, Ontario, Canada
  10. 10Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel
  1. Correspondence to Dr Walter N Kernan; walter.kernan{at}yale.edu

Abstract

Background and purpose Providing participants with evidence-based care for secondary prevention is an ethical and scientific priority for trials in stroke therapy. The optimal strategy, however, is uncertain. We report the performance of a new approach for delivering preventive care to trial participants.

Methods Participants were enrolled in the Insulin Resistance Intervention after Stroke trial, which examined the insulin sensitiser, pioglitazone versus placebo for prevention of stroke and myocardial infarction after ischaemic stroke or transient ischaemic attack. Preventive care was the responsibility of the participants’ personal healthcare providers, but investigators monitored care and provided feedback annually. We studied achievement of 8 prevention goals at baseline and 3 annual visits, with a focus on 3 priority goals: blood pressure <140/90 mm Hg, low-density lipoprotein (LDL) cholesterol <2.59 mmol/L and antithrombotic therapy.

Results The proportion of participants achieving the priority goals was highest for antithrombotic use (96–99% in each year) and similar for blood pressure (66–72% in each year) and LDL (68–70% in each year). All 3 priority goals were achieved by 47–52% of participants in any given year. However, only 22% of participants achieved all 3 goals in each year.

Conclusions A strategy of monitoring care and providing feedback was associated with high average yearly achievement of 3 priority secondary prevention goals, but the majority of trial participants did not persist in being at goal over time.

Trial registration number NCT00091949.

  • transient ischemic attack
  • risk factors
  • secondary prevention
  • ischemic stroke

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/svn-2016-000029

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    Footnotes

    • Contributors CMV, JJS, KLF, JDS and WNK made substantial contribution to concept or design, made substantial contribution to data acquisition, analysis or interpretation, helped draft or revise the work, gave final approval of the manuscript and agreed to be accountable for all aspects of the work. ACS, AHT, SEI, GAF, RC and DT made substantial contributions to data acquisition, analysis or interpretation, helped draft or revise the work, gave final approval of the manuscript and agreed to be accountable for all aspects of the work.

    • Funding The IRIS trial was funded by a research grant (U01NS044876) from the US National Institute of Neurological Disorders and Stroke. Pioglitazone and placebo were provided by Takeda Pharmaceuticals International. GAF is supported by an NIHR Senior Investigator Award.

    • Competing interests JJS reports personal fees from Acorda Therapeutics. CMV has a consulting agreement with Takeda to examine selected IRIS data. SEI reports personal fees from Merck, Janssen, Novo Nordisk, Sanofi, Intarcia, Lexicon, Poxel, Boehringer Ingelheim, Eli Lilly and AstraZeneca, and other support from Takeda outside the IRIS trial. In addition, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Abbott, Merck and Sanofi have provided continuing medical education (CME) funding to SEI employer, Yale University, for projects in which he has been involved. GAF reports personal fees from Lundbeck, Cerevast, Pfizer, Athersys, AstraZeneca, Boehringer Ingelheim and Daiichi Sankyo.

    • Ethics approval Almost 150 ethics committees or IRBs at participating sites.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The trial data will be available in a public database in late 2017.