Status:
COMPLETED
Trial of Lycopene/Ateronon for Secondary Prevention of Coronary Heart Disease
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
CamNutra Ltd.
Cambridge Theranostics Ltd
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 bio...
Detailed Description
Lycopene, a carotenoid mainly found in tomato-based food products, has strong antioxidant properties relative to other carotenoids and has been postulated to play a role in the prevention of coronary ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00939237
Start Date
July 1 2009
End Date
May 1 2011
Last Update
August 19 2014
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115