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1 US Investigator Meeting DIAS-4, Chicago, July 2011 Patient Flow DIAS-3/4.

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Presentation on theme: "1 US Investigator Meeting DIAS-4, Chicago, July 2011 Patient Flow DIAS-3/4."— Presentation transcript:

1 1 US Investigator Meeting DIAS-4, Chicago, July 2011 Patient Flow DIAS-3/4

2 US Investigator Meeting DIAS-4, Chicago, July Study Flow Chart BaselineTreatmentFollow up Hours or Days0h (Day 1)0.5-9h12-24h72h7d or discharge30d90d or w/d Visit window±7h±1d±7d±14d Informed consentX In-/exclusion criteriaX Med/Neuro history & social history inc. risk factors X DemographicsX Randomization callX IMP administrationX 72-H safety infoX Clinical examination NIHSSXXXXXX mRSXXXX Physical/Neuro examXX Ht & WtX BP, PRXXXXXXXX TemperatureXXX 12-lead ECGXX

3 US Investigator Meeting DIAS-4, Chicago, July Study Flow Chart BaselineTreatmentFollow up Hours or Days0h (Day 1)0.5-9h12-24h72h7d or discharge30d90d or w/d Visit window±7h±1d±7d±14d Laboratory Assessments HbA1cX Troponin IXX HematologyXXXXXX CoagulationXXXXXX Clinical chemistryXXXXXX PK samplesX Antibody assessmentXXXX UrinalysisXX Pregnancy testX Imaging Assessments Proximal cerebral arteriesX(X) Infarct volumeXX To identify or exclude ICHXX

4 US Investigator Meeting DIAS-4, Chicago, July Study Flow Chart BaselineTreatmentFollow up Hours or Days0h (Day 1)0.5-9h12-24h72h7d or discharge30d90d or w/d Visit window±7h±1d±7d±14d Pharmacoeconomics SF-36XX EuroQOLXX Resource utilizationXX Safety and concomittant treatment Adverse eventXXXXXXXX Concomitant medicationXXXXXXXX Concomitant non-drug therapies XXXXXXXX

5 US Investigator Meeting DIAS-4, Chicago, July Time Window Stroke Onset Time 0 hr IMP 9 hrs Eligibility Clinical assessments Consent Brain imaging IMP preparation Trial data collection & scales completion 3 hrs Recruitment Time Window Triage Laboratory tests

6 US Investigator Meeting DIAS-4, Chicago, July DIAS-3/4 Tool Kit

7 US Investigator Meeting DIAS-4, Chicago, July Standard Stroke Pathway Routine brain imaging, NIHSS, prestroke mRS, PT/INR, aPTT, platelet count, hematocrit, blood glucose done? Grab DIAS-3/4 Toolkit Informed consent DIAS-3/4 & Stroke Pathway DIAS-3/4 Participation Patient seen for acute stroke (A&E, ward, clinic) Triage/clinical assessment rtPA candidate? Onset within 3-8 hrs rtPA protocol Yes No Stroke care Yes No Yes No Yes Eligible for DIAS-3/4?

8 US Investigator Meeting DIAS-4, Chicago, July Standard Stroke Pathway Do PT/INR, aPTT, platelet count, hematocrit, blood glucose, other laboratory tests, EKG (if not yet done) Informed consent DIAS-3/4 & Stroke Pathway DIAS-3/4 Participation Patient seen for acute stroke (A&E, ward, Clinic) Triage/clinical assessment rtPA candidate? Onset within 3-8 hrs rtPA protocol Yes No Stroke care No 1 hour CT/CTA or MRI/MRA IVRS & IMP preparation Data collection & Scales completion Confirm rest of eligibility criteria IMP administration Ineligible

9 US Investigator Meeting DIAS-4, Chicago, July Time 0h IMP 72h BP every 30 min for 6h then every 1h Clinical exams and laboratory assessments Brain image PK X 2 9h Patient Flow after IMP Administration 12h½h24h7d/dc30d90d Adverse events Concomitant medications/non-drug therapies Pharma-eco

10 US Investigator Meeting DIAS-4, Chicago, July Conclusions Easy study – patient management close to normal practice Similar to rtPA in acute stroke setting Longer time window – 3-9 hours Tool kit and worksheets available Single IV bolus of IMP over 1-2 min Potential rate-limiting factors: Brain imaging to document size of stroke and high- grade stenosis/occlusion IMP to be given within 1 hr of completion of scan Careful planning + flexibility

11 US Investigator Meeting DIAS-4, Chicago, July Thank you!!!


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