FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                               1
Edward P. Sloan, MD...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                                       2
Edward P. S...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                                      3
Edward P. Sl...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                               4
Edward P. Sloan, MD...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                                 5
Edward P. Sloan, ...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                               6
Edward P. Sloan, MD...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                               7
Edward P. Sloan, MD...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                                8
Edward P. Sloan, M...
FERNE: Clinical Trials Research in Neurological Emergencies and Stroke                                                    ...
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SIMEU / ACEP SIMEU / ACEP Emergency Medicine Emergency ...

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SIMEU / ACEP SIMEU / ACEP Emergency Medicine Emergency ...

  1. 1. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 1 Edward P. Sloan, MD, MPH, FACEP Current International Case Studies in Clinical Trials in Cerebrovascular Ischemic and Emergencies Research: Hemorrhagic Stroke Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH SIMEU / ACEP Turino, Italy Emergency Medicine November 9-11, 2006 Congress Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Attending Physician Emergency Medicine Professor University of Illinois Hospital Department of Emergency Medicine Our Lady of the Resurrection Hospital University of Illinois College of Medicine Chicago, IL Chicago, IL Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  2. 2. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 2 Edward P. Sloan, MD, MPH, FACEP Disclosures • NovoNordisk, King Pharmaceuticals, NovoNordisk, UCB Pharma Advisory Boards • Eisai Speakers’ Bureau Speakers’ • ACEP Clinical Policies Committee • ACEP Scientific Review Committee • Executive Board, FERNE • FERNE support by Abbott, Eisai, Pfizer, Edward P. Sloan, MD, MPH UCB Edward P. Sloan, MD, MPH Board Chairman and President FERNE Chicago, IL www.ferne.org Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH A Special Welcome To… Today’s Agenda William Barsan, MD FACEP • Present the current clinical situation • Review two articles and editorials Jonathan Edlow, MD, FACEP • Consider the research impact J. Stephen Huff, MD, FACEP • Consider the clinical care impact Andrew Jagoda, MD, FACEP • Project future work and collaboration Our Italian hosts. Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  3. 3. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 3 Edward P. Sloan, MD, MPH, FACEP Ischemic Stroke Patient • 67 year old male • Pt experiences L sided weakness Clinical Cases • Occurs during breakfast • Slurred speech • Arrives by EMS to the ED in 30 min • Accucheck 300 Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Hemorrhagic Stroke Pt • 58 year old female • Pt with a change in mental status • Headache, not feeling well Learning Objectives • Went back to bed and Key Clinical • Found by family less responsive • Arrives by EMS to the ED in 15 min Questions • Blood pressure 228/126 Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Session Objectives Session Objectives • Discuss the impact of the negative SAINT • Determine how the data from these large II trial of NXY-059 on the development of NXY- international trials can improve the care an effective neuroprotectant for the of acute stroke patients even if the treatment of ischemic stroke patients. results of the clinical trials do not identify • Review the current status of the clinical a new effective therapy. trials of Factor VIIa in the treatment of • Consider how the NETT research intracerebral hemorrhage and the consortium might enhance CNS differences between these clinical trials emergencies clinical trials research in and those of NXY-059. NXY- the US and internationally. Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  4. 4. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 4 Edward P. Sloan, MD, MPH, FACEP Key Clinical Questions Key Clinical Questions • What can be learned from the • How can the data from these clinical international clinical trials of NXY- NXY- trials be successfully analyzed so 059 and Factor VIIa regarding that the story can be told of how neurological emergencies clinical acute ischemic and hemorrhagic trial design and conduct? conduct? stroke patients can be optimally managed in the 21st century, especially in the area of tPA use in ischemic stroke? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Key Clinical Questions Key Clinical Questions • How can the formation of NETT in • What are the best next steps to be the US be leveraged to enhance taken be leaders in the field of international research and neurological emergencies research, collaboration in the area of acute patient management, clinical trials neurological emergencies patient design, clinical policy formation, management? patient advocacy, and public health? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH NXY-059 Clinical Data • Neuroprotectant NXY-059: • Remains intravascular • Does not cross blood brain barrier Clinical and • Protects neurons Research Data Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  5. 5. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 5 Edward P. Sloan, MD, MPH, FACEP NXY-059 Research Data NXY-059 Publications • SAINT I positive phase III trial • NEJM Feb 2006 article • 1722 patients • Lees et al • Improved outcome using mRS • Multinational phase III clinical trial • Reduced tPA significant ICH rate • SAINT II confirmatory trial: 3000 pts • NEJM Feb 2006 editorial • SAINT II phase III trial negative • del Zoppo • “Stroke & Neurovascular Protection” Protection” Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Key Clinical Questions Key Clinical Questions • Clinical trials often will generate • The FDA requries paired phase III different results given differences in clinical trials in order for efficacy to patient populations and standard be demonstrated. therapies. • Should paired trials be required for • What should be done if one trial is all drugs in development? positive and the other neutral? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Key Clinical Questions Key Clinical Questions • What is a possible explanation of • Emergency physicians utilize many these two clinical trials not having therapies that provide the same results? neuroprotection: airway, blood pressure, and ICP/cerebral perfusion control being the most important. • Is neuroprotection possible using a specific neuroprotectant? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  6. 6. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 6 Edward P. Sloan, MD, MPH, FACEP Key Clinical Questions • The proposed number needed to treat in the SAINT I trial was Factor VIIa: approximately 24. • The NNT in the tPA clinical trials was Clinical and approximately 8. Research Data • What does this suggest about the efficacy of IV tPA in ischemic stroke? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Factor VIIa Clinical Data Factor VIIa Research Data • Anticoagulant • Positive phase III trial • Final common pathway agent • 399 patients • Used to treat hemophilia patients • Reduced hemorrhage volume • Reduces hemorrhage volume in ICH • Improved outcome using mRS patients volume via hemostasis • Increased thromboembolic events • Confirmatory trial taking place Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Factor VIIa Publications Key Clinical Questions • NEJM Feb 2005 article • What is the number needed to treat • Mayer et al with this therapy in order to • Multinational phase III clinical trial provided the best clinical outcome? • NEJM Feb 2006 editorial • Brown and Morgenstern • “Stopping the Bleeding in ICH” ICH” Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  7. 7. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 7 Edward P. Sloan, MD, MPH, FACEP Key Clinical Questions Key Clinical Questions • What can be learned about the use • This drug is already FDA approved of the modified Rankin Scale in the and can and is already being used clinical trials and treatement of by clinicians for ICH patients. stroke patients? • How can this situation be optimally managed? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Key Clinical Questions • What will happen if the second confirmatory trial is neutral and Clinical Trials Data: clinicians alraedy are used to including this therapy in the Providing Maximal management of ICH patients? Benefit Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Key Clinical Questions Key Clinical Questions • How can we best access and publish • What might be learned from the tPA data from industry sponsored data contained within the NXY-059 NXY- clinical trials? clinical trials, especially with regards to tPA use in the ED? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  8. 8. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 8 Edward P. Sloan, MD, MPH, FACEP Key Clinical Questions Key Clinical Questions • What might be learned about the • What can be learned about outcome clinical practice of Emergemcy measures such as the modified Medicine and the resuscitation of Rankin Scale and their use in clinical acute stroke patients from these trials research? clinical trials? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Key Clinical Questions • How can the detailed clinical trials Coordinated Research conducted by industry be performed by NETT? & NETT: How Can This Opportunity Be Leveraged Internationally? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Key Clinical Questions Key Clinical Questions • What role for NETT is envisioned for • Could a reserch network such as the development of clinical trials NETT be developed in Italy in order that answer important stroke patient to enhance clinical care, research, care questions? and the specialty of Emergency Medicine? Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH
  9. 9. FERNE: Clinical Trials Research in Neurological Emergencies and Stroke 9 Edward P. Sloan, MD, MPH, FACEP Key Clinical Questions Conclusions • Important neurological emergencies • Could a reserch network such as research being conducted by industry NETT be developed in the EU in • Much can be learned from these order to enhance clinical care, protocols and the patients treated in the research, and the specialty of context of this clinical trials research Emergency Medicine? • It is an opportunity for emergency physicians to better understand our clinical practice • Opportunities for international work exist Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH Recommendations • We should closely monitor the outcomes of these clinical trials Questions? • A concerted effort to analyze all aspects of these clinical trials should be made www.FERNE.org • Collaboration with industry and government should be enhanced edsloan@uic.edu 312 413 7490 • Examination of opportunities abroad should be made ferne_simeu_2006_sloan_neuroprotection_111006_final 12/21/2006 9:44 AM (11/10 1126 am) Edward P. Sloan, MD, MPH Edward P. Sloan, MD, MPH

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