Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction [C14.907.585.500]

Treatments: Drug: High-dose Rosuvastatin; Drug: Low-dose Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01245894

VF-20060

Details and patient eligibility

About

The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.

Enrollment: 87 patients

Sex: All

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ST-segment elevation myocardial infarction
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. hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
5. current liver disease (ALAT > 2 x ULN),
6. unexplained creatine kinase > 3 x ULN,
7. alcohol or drug abuse within the last five years,
8. prior myopathy or serious hypersensitivity reaction caused by statins,
9. women with childbearing potential who were not using chemical or mechanical contraception,
10. pregnant or breastfeeding women,
11. history of malignancy unless a disease-free period of more than five years was present,
12. patients with abnormal lung function test (LFT),
13. participation in another investigational drug study less than four weeks before enrolment in the present study,
14. 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

Low-dose Rosuvastatin

Active Comparator group

Description:

5mg Rosuvastatin/day

Treatment:

Drug: Low-dose Rosuvastatin

High-dose Rosuvastatin

Active Comparator group

Description:

Rosuvastatin 40mg/day

Treatment:

Drug: High-dose Rosuvastatin