PI and Coordinator Webinar September 24, 2019

Site startup 124 sites released to enroll 91 sites with at least one randomization 122 sites with at least one consent

Enrollment 1,216 patients consented 313 randomized

Top enrolling sites – by # randomized Consented United 14 40 Cincinnati 12 36 Iowa 9 38 OHSU 35 Intercoastal 8 30 Kentucky 27 Memorial Hermann 25 Penn Mayo San Mary's 23

Top enrolling sites – by randomization rate Randomized/Month Consented/Month North Shore 1.00 1.3 Mississippi 0.95 2.6 United 0.83 2.4 Emory 0.64 2.5 Cincinnati 0.61 1.8 Kentucky 0.56 1.9 OHSU 0.54 2.1 Mayo San Mary's 0.53 1.5 Greenville 0.51 Iowa

Coordinator hero Jay Sherman, WVU Healthcare Ruby Memorial Hospital, WV A consented patient who was eligible for randomization lived quite far, but that didn’t deter him. Jay contacted us to make sure he could properly handle the samples during the long trip to and fro and got the job done!

Coordinator hero Khadean Moncrieffe, Montefiore Worked with the ARCADIA team to consent and randomize an outpatient potential subject in less than 24 hours!

Emergency unblinding Please reinforce importance of subject having wallet card with them at all times—unblinding without Subject ID will be challenging and may lose valuable time! Unblinding should only be considered when there is an implication for immediate emergency treatment Study medications can be stopped temporarily for planned medical procedures (unblinding is not needed, and study meds can be restarted once safe)

Reminders Please don’t “pre-screen”. You will lose out on eligible patients! LAR vs. witness consent. LAR if no cognitive capacity, witness if no physical capacity, illiteracy, or translator use. Concomitant enrollment in observational studies is okay (please check in with us though).

The Road to Success! Most important and first step “Why are we doing this study?” Getting your department on board! -Lunch & Learn -Pocket cards with inclusions/exclusions for residents & NP’s Streamline Consent process Making the most of the participants time while inpatient Maintain communication after they leave hospital If the SC can’t address any concerns, involve the PI right away! Maintain a positive attitude throughout the study process PI: Dr. Shashank Shekhar Study Coordinator: Susan Hetzel, RN

 Talk… PI/ Residents Research Coordinator Consent NP’s Attending Screening Yes Educate about stroke and why we suspect ESUS in that patient Show pictures, draw figures and explain the mechanism of stroke Breakdown the benefit of the study in 4-5 points Aspirin may not be best treatment Will receive special attention from research team Will get treatment free of cost If has atrial cardiopathy then 50% more chance of receiving Apixaban if participate in the study and eligible for study Will still do tests to rule out Afib/aflutter etc. Patient gets initial heads up treatment team about the study

DOA Process cIRB is no longer requiring DoA log changes to be sent for approval PM is now approving changes Process Have “people documents” in hand ready to be uploaded CV, HSP Training, License, mRS, NIHSS, Protocol & SC Trainings, etc… Complete modification on DoA log in WebDCU PM will get notification of DoA log change and will review for approval Site will receive WebDCU alert that the change has been approved Site to immediately upload all “people documents” PM will check WebDCU for documents, review, and approve After documents are approved the new team member is approved to work on the study

fCOI Responsibilities StrokeNet will only be collecting the fCOI form for the following: All PIs Any team member that has a positive disclosure New Process Follow your institution’s policy on fCOI and maintain forms at your site If your institution does not have a policy it is suggested that the fCOI be tracked yearly If a team member has a positive disclosure, that fCOI form is emailed to the PM for submission to the cIRB for review All PIs will complete the StrokeNet fCOI form yearly and upon start of any new study. The fCOI form is uploaded into WebDCU for review

FAQs Question: Our patient had a run of SVT on their post-stroke Holter monitor. No evidence of afib or aflutter. Is it OK to enroll?

FAQs Question: Our patient had a run of SVT on their post-stroke Holter monitor. No evidence of afib or aflutter. Is it OK to enroll? Answer: Yes. Only afib or aflutter on heart-rhythm monitoring is an exclusion.

FAQs Question: The patient’s most recent echo EF was 43%; however, her previous EF history was around 30%. Can we move forward with consenting this patient tomorrow?

FAQs Question: The patient’s most recent echo EF was 43%; however, her previous EF history was around 30%. Can we move forward with consenting this patient tomorrow? Answer: Yes. As long as EF is 30% or greater and reasonably expected to stay that way. The current value is used to determine eligibility.

FAQs Question: How long after stopping Plavix can we start study drug? Answer: A. Immediately. B. 12-24 hours. C. 48-72 hours. D. 1 week.

FAQs Question: How long after stopping Plavix can we start study drug? Answer: B. 12-24 hours (per site PI’s discretion).

Feel free to reach out! 24-hour telephone hotline Please use it for any urgent questions Eligibility, randomization, unblinding, etc 1-877-427-2234 (1-877-4AR-CADI): useful to save in your cell phone The hotline automatically calls the four PIs in succession Please let it ring And call back if no luck—one of us will pick up! Please email arcadia@ucmail.uc.edu with non-urgent questions