Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Endothelial Dysfunction; Atherosclerosis

Treatments: Drug: Rosuvastatin 5mg/day; Drug: Rosuvastatin 40mg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT01223625

VF-200600

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 endothelial function.

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

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. hypothyreoidism ((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/day

Active Comparator group

Description:

Rosuvastatin 5mg/day

Treatment:

Drug: Rosuvastatin 5mg/day

Rosuvastatin 40mg/day

Active Comparator group

Description:

Rosuvastatin 40mg/day

Treatment:

Drug: Rosuvastatin 40mg/day