Working Group on Future Clinical Research Directions on
Omega-3 Fatty Acids and Cardiovascular Disease

Bethesda Marriott Hotel
5151 Pooks Hill Road
Bethesda, MD 20817

June 2, 2004

AGENDA

8:00 a.m. - 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. - 8:45 a.m.

Welcome and Charge to the Working Group

Dr. Obarzanek, Dr. Coates, Dr. Grundy

Part I: Review of Evidence-Based Reports
Moderator: Dr. Appel

8:45 a.m. - 9:15 a.m.

Summary of Methods and Approach of Evidence-Based Reports

Dr. Balk

9:15 a.m. - 10:00 a.m.

CVD Risk Factor Report: Summary of Conclusions

Dr. Siscovick

Discussant

Dr. Kris-Etherton

10:00 a.m. - 10:15 a.m.

Break

10:15 a.m. - 11:00 a.m.

CVD Report: Summary of Conclusions

Dr. Jacobson

Discussant

Dr. Guallar

11:00 a.m. - 11:30 a.m.

Discussion: Evidence and Need for Trial

All

11:30 a.m. - 12:00 noon

Recommendations for Research to Help

Prepare or complement a Trial

All

12:00 noon

Working Lunch

Part II: Considerations of Intervention
Moderator: Dr. Albert

12:30 p.m. - 1:00 p.m.

Possible Omega-3 Fatty Acid Interventions

Dr. Harris

1:00 p.m. - 1:30 p.m.

Alpha Omega Trial: Example of Two Interventions

Dr. Geleijnse

Part III: Considerations of Types of Trials
Moderator: Dr. Grundy

For the following three types of trial populations (acute coronary syndrome patients, secondary prevention patients, and primary prevention for high-risk populations), discuss design and implementation considerations regarding:

• Eligibility criteria to define the population
• Trial setting (e.g., multiple clinical centers, mail)
• Intervention(s)
  • Number of arms
  • Type of Omega-3 (e.g., fish-based, plant-based)
  • Delivery (e.g., supplement, food)
  • Dose
  • Blinding
  • Adherence issues
• Outcomes (primary, secondary, safety, others)
• Critical design assumptions
  • Effect size
  • Possible event rates
  • Duration
  • Possible sample size (rough estimate)

1:30 p.m. - 2:30 p.m.

Acute Coronary Syndrome Patients

Moderator: Dr. Blazing

All

2:30 p.m. - 3:30 p.m.

Secondary Prevention Patients

Moderator: Dr. Sacks

All

3:30 p.m. - 4:00 p.m.

Break

4:00 p.m. - 5:00 p.m.

Primary Prevention for High-Risk Populations

Moderator: Dr. Appel

All

5:00 p.m. - 5:30 p.m.

Wrap-Up and Next Steps

Dr. Grundy, Dr. Obarzanek

5:30 p.m. Adjourn