Trial of Lycopene/Ateronon for Secondary Prevention of Coronary Heart Disease

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Ateronon, a nutritional supplement that contains lycopene from tomatoes has a favorable effect on carotid atherosclerosis, lipid levels, and other biomarkers of coronary heart disease.

The trial was stopped early due to insufficient financial support from the initial study collaborator, Cambridge Theranostics Ltd. Collected patient data are sufficient for final trial-based analyses to be conducted with financial support from the new study collaborator, CamNutra Ltd. The data will still be analyzed according to the original study aims.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Cambridge Theranostics Ltd; CamNutra Ltd.
• Treatments: Lycopene

Criteria

Inclusion Criteria:

• Brigham and Women's Hospital Cardiology Clinic patients with history of coronary heart disease occurring at least 6 months ago:

• history of myocardial infarction (MI) confirmed by medical records AND/OR

• history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)

• Compliance during run-in as demonstrated by taking at least 66% of study medications

• Ability and willingness to complete questionnaires concerning medical history, concomitant medication use, coronary heart disease risk factors, potential adverse events, and diet

Exclusion Criteria:

• History of carotid stent, carotid endarterectomy, or carotid artery surgery

• History of diagnosed congestive heart failure meeting New York Association Functional Classification III or IV criteria

• Any initiation or change in statin use or other lipid-lowering treatment within 3 months of randomization

• Lactose intolerance

• Allergies to whey protein

• Allergies to soy protein

• History of active cancer diagnosis (except non-melanoma skin cancer) within last 3 years

• Life expectancy < 1 year

• Women who are pregnant, nursing, or intend pregnancy during the period of treatment

• Plan to relocate out of Boston area within the next year

• Inability to provide informed consent

• Carotid artery occlusion or dissection at baseline carotid IMT assessment