9:00AM - Welcome/Introduction
Karen A. Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products (DCRP), CDER

9:05AM - Opening Remarks
Norman L. Stockbridge, MD, PhD
Director, Division of Cardiovascular and Renal Products (DCRP), CDER

9:15AM - Update since September 11, 2009 Meeting
Karen A. Hicks, MD

9:30AM - Testing the Definitions: Internal Results and Future Plans
Testing the Definitions: Internal Results
Stephen D. Wiviott, MD, FACC
Investigator, TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital
and
Testing the Definitions: Future Plans
Eldrin Lewis, MD, MPH
Associate Director, Clinical Endpoints Center, Brigham and Women's Hospital

10:00AM - BREAK

10:15AM - Discussion of Team 1 Definitions

• Myocardial Infarction
• Cardiovascular Death
• Non Cardiovascular Death
• Undetermined Cause of Death
• Bleeding

Ken William Mahaffey, MD
Associate Professor of Medicine: Faculty Director of Cardiovascular Mega-Trials; Director of Clinical Events Classification (CEC) Group, Duke Clinical Research Institute (DCRI)

11:15AM - Discussion of Team 2 Definitions

• Stroke
• Coronary Revascularization Procedure
• Peripheral Revascularization Procedure
• Stent Thrombosis

Draft Definitions: Revascularization and Stent Thrombosis
Roxana Mehran, MD
Team Leader, Group 2
Associate Professor of Medicine, Director of Outcomes Research, Data Coordination, and Analysis; Center for Interventional Vascular Therapies, Columbia University Medical Center; Joint Chief Scientific Officer, Cardiovascular Research Foundation
and
Stroke Definition
Billy Dunn, MD
Team Leader, Division of Neurology Products, CDER
and
John Marler, MD
Medical Officer, Division of Neurology Products, CDER
and
Assessing Stroke Severity
Cathy A. Sila, MD
George M. Humphrey II Professor of Neurology, Director, Stroke & Cerebrovascular Center, Neurological Institute Case Medical Center, Case Western Reserve University School of Medicine

12:15PM - LUNCH

1:15PM - Discussion of Team 3 Definitions

• Hospitalization for Unstable Angina
• Hospitalization for Congestive Heart Failure

Steve Nissen, MD, MACC
Team Leader, Group 3
Chairman, Department of Cardiovascular Medicine, Cleveland Clinic Foundation

2:15PM - Women CRF
Roxana Mehran, MD / Karen A. Hicks, MD
Salma Lemtouni, MD, MPH
Medical Officer, Office of Women's Health

3:15PM - BREAK

3:30PM - Data Standards: Future Plans
Bron Kisler, CDISC
Brian McCourt, DCRI

4:30PM - Wrap-up / Future Plans / Adjournment
Karen A. Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products (DCRP), CDER