1. The Cardiovascular Inflammation Reduction Trial (CIRT)
Investigator and Coordinator Teleconference
October 30, 2014
Elaine Zaharris
CIRT Project Manager
Aruna Pradhan, MD, MPH
Assistant Professor of Medicine
Harvard Medical School
Director, Preventive Medicine Cohorts Biorepository
Brigham and Women’s Hospital, Boston MA
7/24/2014

2. Agenda for Call Recruitment Overview – Elaine Zaharris
Acknowledging Drug Receipt
Subject Withdrawals
Upcoming Protocol Amendment
Q and A
10/30/2014 2

3. Recruitment Overview Sites Participants 459 interested
393 with IRB approval
369 ready to screen
295 with 1+ participants screened
230 with 1+ participants randomized
Participants
2637 with informed consent
2555 screened
1123 randomized (as of October 29, 2014)
10/30/2014 3

4. Women and Minority Recruitment
Total
Women
Minority
Screened
2540
606
733
Percent (%)
100
23.9
28.9
Total
Women
Minority
Randomized
1106
230
270
Percent (%)
100
20.8
24.4
Data as of 10/24/14
10/30/2014

5. Agenda for Call Recruitment Overview – Elaine Zaharris
Acknowledging Drug Receipt
Subject Withdrawals
Upcoming Protocol Amendment
Q and A
10/30/2014 5

6. Acknowledging Drug Receipt
Necessary for dispensing randomization drug packs
Site Initiation or Study Drug Resupply
RANDOMIZATION CAPABILITY
EDC Updated with Pack Numbers and Availability at Study Site
FAX Back Acknowledgement FORM to 1) Catalent
2) CIRT CC
Drug Shipment from Catalent
Drug Arrival at Study Site
10/30/2014

7. “Shipment Request & Acknowledgement Form”
Pre-filled, Site-Specific
Completed By Site
FAX TO BOTH #s
Arrives in the Box

8. Agenda for Call Recruitment Overview – Elaine Zaharris
Acknowledging Drug Receipt
Subject Withdrawals
Upcoming Protocol Amendment
Q and A
10/30/2014 8

9. Subject Withdrawals Some Definitions:
Withdrawal = subject withdraws consent
Passive Follow-Up = permanent stop (as with subjects having a confirmed primary EP)
Active Follow-Up = in study on drug
10/30/2014

10. Subject Withdrawals NO REASON FOR IT!!
Goal is to keep subjects in active follow-up on study drug.
When any and all attempts fail, then passive follow-up with continued completion of study visits.
Subject withdrawal (consent withdrawal) should never happen at your site!
If a subject at your site has withdrawn, we ask that you approach them for reinstatement in the trial. We will assist with EDC modification to facilitate this.
10/30/2014

11. Subject Withdrawals: Examples
Mrs. S does not feel she can comply with blood draw schedule.
Connect with her
Remind her that after the first six months, blood draw frequency declines to bimonthly
Remind her of the science behind the study and of the importance of her contributions
Remind her that blood testing is precautionary
Remind her that she can go to a PSC for most draws at her own convenience
10/30/2014

12. Subject Withdrawals: Examples
Mr. M develops a primary endpoint.
This results in a permanent stop BUT NOT subject withdrawal from the trial
Mr. M should be reinstated in the trial (we will help you with how to do this operationally)
He should be retained in passive follow-up
10/30/2014

13. Agenda for Call Recruitment Overview – Elaine Zaharris
Acknowledging Drug Receipt
Subject Withdrawals
Upcoming Protocol Amendment
Q and A
10/30/2014 13

14. Upcoming Protocol Amendment
Qualifying event will be expanded to include ANY PAST history of documented myocardial infarction or multi-vessel coronary artery disease
No recency qualifier.
10/30/2014

15. Qualifying Event: New Eligibility Criteria
Documented past history of myocardial infarction
Documented past angiographic evidence of multi-vessel coronary artery disease (stent, bypass graft, or angiographic lesion of > 60% in 2 major epicardial vessels or > 50% isolated left main stenosis)
10/30/2014

16. What documentation is required?
Myocardial infarction
Hospital discharge record
Current EKG with Q waves in 2 contiguous leads
Echo with scar or clear wall motion abnormality
Nuclear stress test showing scar or wall motion abnormality
Angiographic evidence of multivessel CAD
Cardiac catheterization report
Operative report (PCI or CABG)
Not Accepted: Coronary CTA
AS BEFORE BUT:
NO TIME LIMIT
10/30/2014

17. Protocol Amendments Protocol Amendment BWH IRB CCC DSMB Copernicus
Local IRBs
IRB Services
EDC
System
Recruitment Materials
Manual of Operations
Quick Reference Card
10/30/2014

18. Protocol Amendments Protocol Amendment BWH IRB CCC DSMB Copernicus
Local IRBs
IRB Services
EDC
System
Recruitment Materials
Manual of Operations
Quick Reference Card
10/30/2014

19. Agenda for Call Recruitment Overview – Elaine Zaharris
Acknowledging Drug Receipt
Subject Withdrawals
Upcoming Protocol Amendment
Q and A
10/30/2014 19

20. Next Coordinator Call November 20, 2014 at 12pm Eastern
Thank you for your attention!
10/30/2014