Supplementation of Lycopene in Carotid Atheroma "SOLANUM"

Withdrawn

Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Age 40 - 90 years old,
- Clinically documented carotid symptomatic atherosclerotic disease (symptomatic disease will be considered if one of the following has occurred within 2 months prior to symptoms:
1. Amaurosis fugax
2. Transient ischemic attack (TIA)
3. Stroke (ipsilaterally to the stenotic artery)
- >30% stenosis on initial B-mode ultrasonography imaging,
- Written, informed consent.

Exclusion Criteria

- Age <40 years old or >90 years old,
- Time from symptom to recruitment > 2 months
- <30% stenosis on B-mode ultrasonography imaging,
- Scheduled for surgical/endovascular intervention within 3 months,
- High-dose statin therapy (>80 mg/day fluvastatin; >40 mg/day simvastatin; >40 mg/day pravastatin; >10 mg/day atorvastatin; >10 mg/day rosuvastatin 21),
- Other lipid-lowering therapy (fibric acid derivatives, niacin ≥250 mg/day, resins, ezetimibe, fish-oil supplements),
- Chronic use of high dose aspirin >325 mg/day,
- Allergy or hypersensitivity to tomatoes and tomato products, gadolinium and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin),
- Contraindications for MRI studies including claustrophobia, any MRI non-compatible devices implanted (vascular clips, metal sutures, craniofix, cardiac pacers, endovascular stents/coils, etc.),
- Known renal impairment with creatinine clearance <50 ml/min (as per departmental policy),
- Women of childbearing potential,
- Inability to consent