Effects of Crestor on Inflammation of Atherosclerotic Plaques

AstraZeneca

Status and phase: Completed; Early Phase 1

Conditions: Inflammatory Activity in Carotid Arteries; Atherosclerosis

Treatments: Drug: rosuvastatin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689416

D4411M00010

Details and patient eligibility

About

The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these techniques are promising for future proof of principle studies. A number of patients will receive placebo as a control.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with a non-calcified plaque of at least 2 mm over an at least 6 mm length on first MR scan with an uptake of contrast agent on the dynamic MRI scan
• Signed written Informed Consent.
• Healthy men 18 - 70 years, women 60 - 70

Exclusion criteria

• Use of a statin within six months before randomization.
• Use of lipid altering medication other than statins within the last six months.
• Clinical evidence of metabolic or vascular disease requiring statin or other lipid lowering pharmacological or non-pharmacological treatment.
• Total cholesterol > 8, LDL-C > 6 or TG > 6 mmol/L at enrolment

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: rosuvastatin

2

Placebo Comparator group

Treatment:

Drug: placebo