Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Subclinical Carotid Atherosclerosis; ST-segment Elevation Myocardial Infarction

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01203982

VF-20060060

Details and patient eligibility

About

The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate marker of cardiovascular risk.

Full description

The aim of this study was to measure the effect of moderate (5mg) and intensive (40mg) lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness as a surrogate marker of cardiovascular risk and to obtain whether CIMT correlated with the plaque components in coronary arteries evaluated with Intravascular Ultrasound Virtual Histology (IVUS-VH).

Enrollment: 87 patients

Sex: All

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. STEMI,
2. no prior treatment with statins and
3. a non significant lesion in one of the two non-culprit coronary arteries. -

Exclusion criteria

1. age below 18 or above 81 years,
2. unconscious patients,
3. serum creatinine > 176μmol/L,
4. total-cholesterol > 7.0 mmol/l,
5. hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
6. current liver disease (ALAT > 2 x ULN),
7. unexplained creatine kinase > 3 x ULN,
8. alcohol or drug abuse within the last five years,
9. prior myopathy or serious hypersensitivity reaction caused by statins,
10. women with childbearing potential who were not using chemical or mechanical contraception,
11. pregnant or breastfeeding women,
12. history of malignancy unless a disease-free period of more than five years was present,
13. patients with abnormal lung function test (LFT),
14. participation in another investigational drug study less than four weeks before enrolment in the present study,
15. treatment with cyclosporine or fibrates. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 2 patient groups

Rosuvastatin 5mg

Active Comparator group

Description:

Rosuvastatin 5mg/day

Treatment:

Drug: Rosuvastatin

Drug: Rosuvastatin

Rosuvastatin 40mg

Active Comparator group

Description:

Rosuvastatin 40mg/day

Treatment:

Drug: Rosuvastatin

Drug: Rosuvastatin