Lycopene Following Aneurysmal Subarachnoid Haemorrhage (LASH)

University of Cambridge

Status and phase: Unknown; Phase 2

Conditions: Subarachnoid Hemorrhage; Aneurysm

Treatments: Drug: placebo; Drug: Lycopene

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00905931

LASH 3

Details and patient eligibility

About

In this study the investigators wish to explore the potential neuroprotective effects of acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on cerebral vasospasm and autoregulation, and examine whether any improvements translate into a reduction of biochemical markers of vascular injury and inflammation a decrease in the prevalence of secondary strokes following subarachnoid haemorrhage.

Enrollment: 124 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: > 18 years old,
• Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
• Time from ictus < 96 hours

Exclusion criteria

• Age: < 18 years old,
• Non-aneurysmal SAH,
• Time from ictus > 96 hours,
• Severe carotid atherosclerotic disease (≥70%)
• High-dose statin therapy (>80 mg/day fluvastatin; >40 mg/day simvastatin; >40 mg/day pravastatin; >10 mg/day atorvastatin; >10 mg/day rosuvastatin 28),
• Allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: Lycopene

Placebo

Placebo Comparator group

Treatment:

Drug: placebo