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Study Protocol Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial Study Protocol Supported by The National Institute of Neurological Disorders and Stroke (NINDS) Principal Investigator S. Claiborne Johnston, MD, PhD Professor of Neurology and Epidemiology University of California San Francisco Co-Principal Investigator J. Donald Easton, MD Clinical Professor of Neurology University of California San Francisco Co-Principal Investigator Anthony Kim, MD, MAS Clinical Professor of Neurology University of California San Francisco Protocol Version 6.0 NCT00991029 EudraCT 2013-001185-41 POINT Trial Protocol INVESTIGATOR PROTOCOL SIGNATURE PAGE Protocol Version (6.0) dated (30NOV2016) I have read this protocol and agree to adhere to the requirements. I will provide copies of this protocol and all pertinent information to the study personnel under my supervision. I will discuss this material with them and ensure they are fully informed regarding the investigational plan and the conduct of the study, applicable laws, regulations, international standards, and ethical and safety considerations, including 21 CFR Parts 50, 54 and 56, International Conference on Harmonization (ICH) Good Clinical Practices (GCP) Guidelines, and Institutional Review Board (IRB) or Ethics Committee (EC) requirements. _____________________________________ ________________ Clinical Site Date _____________________________________ ________________ Site Principal Investigator Signature Date _____________________________________ ________________ Site Principal Investigator Printed Name Date Version 6.0 29 February 2016 Amended: 11.30.2016 Page 2 POINT Trial Protocol COUNTRY COORDINATOR PROTOCOL SIGNATURE PAGE Protocol Version (6.0) dated (30NOV3018) I have read this protocol and agree to adhere to the requirements. I will provide copies of this protocol and all pertinent information to the study personnel under my supervision. I will discuss this material with them and ensure they are fully informed regarding the investigational plan and the conduct of the study, applicable laws, regulations, international standards, and ethical and safety considerations, including 21 CFR Parts 50, 54 and 56, International Conference on Harmonization (ICH) Good Clinical Practices (GCP) Guidelines, and Institutional Review Board (IRB) or Ethics Committee (EC) requirements. _____________________________________ ________________ Country/Clinical Site Date _____________________________________ ________________ Country Coordinator Signature Date _____________________________________ ________________ Country Coordinator Printed Name Date Version 6.0 29 February 2016 Amended: 11.30.2016 Page 3 POINT Trial Protocol Table of Contents PROTOCOL SIGNATURE PAGE .................................................................................................................... 2 Table of Contents ....................................................................................................................................... 4 POINT PROTOCOL SYNOPSIS ...................................................................................................................... 8 1 STUDY FLOWCHARTS ........................................................................................................................ 12 1.1 Graphical Study Design ............................................................................................................. 12 1.2 Schedule of Activities and Assessments ................................................................................... 13 2 BACKGROUND AND SIGNIFICANCE ................................................................................................... 14 2.1 TIA Incidence ............................................................................................................................ 15 2.2 Short-term Prognosis ............................................................................................................... 15 2.3 Underlying Pathophysiology of TIA and Minor Ischemic Stroke .............................................. 17 2.4 Potential Therapies .................................................................................................................. 17 2.4.1 Aspirin ................................................................................................................................... 18 2.4.2 Clopidogrel ........................................................................................................................... 18 2.4.3 Combination Clopidogrel-Aspirin ......................................................................................... 19 2.4.4 Dipyridamole ........................................................................................................................ 22 2.5 Advantages of a TIA Acute Treatment Trial ............................................................................. 22 2.6 Preliminary Studies ................................................................................................................... 22 2.6.1 Predictors of Stroke Risk after TIA ........................................................................................ 23 2.6.2 Importance of Recovery: Risk of Stroke after Recovery in NINDS tPA, TOAST Trials .......... 24 2.6.3 Current Utilization of Antithrombotics after TIA .............................................................. 24 3 STUDY OBJECTIVES ............................................................................................................................ 25 3.1 Secondary ................................................................................................................................. 25 4 STUDY DESIGN AND MANAGEMENT OVERVIEW .............................................................................. 25 4.1 Study Design Overview ............................................................................................................. 25 4.2 Study Milestones ...................................................................................................................... 26 4.3 Organizational Structure and Communication Flow ................................................................ 26 4.3.1 Trial Organization ................................................................................................................. 29 4.4 Site Training, Certification, and Update ................................................................................... 29 Version 6.0 29 February 2016 Amended: 11.30.2016 Page 4 POINT Trial Protocol 4.5 Contact Schedule and Measurements ..................................................................................... 30 4.6 Outcomes ................................................................................................................................. 30 4.6.1 Definitions of Clinical Outcomes/Serious Adverse Events ................................................... 30 5 PARTICIPANT SELECTION .................................................................................................................. 33 5.1 Study Population ...................................................................................................................... 33 5.2 Inclusion and Exclusion Criteria ................................................................................................ 34 6 TREATMENTS ..................................................................................................................................... 35 6.1 Study Drugs .............................................................................................................................. 35 6.2 Assignment to a Treatment Group ........................................................................................... 36 7 STUDY DRUG HANDLING ................................................................................................................... 36 7.1 Supply and Storage ................................................................................................................... 36 7.2 Packaging .................................................................................................................................. 37 7.3 Responsibilities ......................................................................................................................... 38 7.4 Concurrent Treatment.............................................................................................................. 38 7.4.1 Prohibited Concomitant Treatments.................................................................................... 38 7.4.2 Permitted Concurrent Treatments ....................................................................................... 38 7.5 Treatment Discontinuation ...................................................................................................... 39 7.5.1 Permanent Treatment Discontinuation ............................................................................... 39 7.6 Blinding System and Emergency Unblinding Procedure .......................................................... 40 8 SAFETY ............................................................................................................................................... 40 8.1 Protection/ Minimization of Risk.............................................................................................. 40 8.2 Serious Adverse Events ...........................................................................................................
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