Clinical trial NCT01203982: Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)
Official title: Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima Media Thickness and Its Relation to Plaque Components of the Coronary Arteries in Patients With ST-Segment Elevation Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST-segment Elevation Myocardial Infarction
Subclinical Carotid Atherosclerosis
Keywords: CIMT
IVUS-VH
Coronary artery disease
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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. -

Primary outcomes:
measure: change from baseline in mean CIMT
timeFrame: baseline, 6month, 12 month
Secondary outcomes:
measure: changes from baseline in max CIMT
timeFrame: baseline, 6month, 12 month
measure: change from baseline in mean common CIMT
timeFrame: baaseline, 6month 12 month
measure: change from baseline in max common CIMT
timeFrame: baseline, 6month 12month
measure: change from baseline in mean bulbus CIMT
timeFrame: Baseline, 6month 12 month
measure: change from baseline in max bulbus CIMT
timeFrame: baseline, 6month 12month
measure: change from baseline in lipid values
timeFrame: baseline, 6month 12month
measure: correlation between CIMT measurements and lipid values
timeFrame: Baseline, 6month 12 month
measure: correlation between CIMT measurements and plaque components evaluated by IVUS-VH
timeFrame: Baseline, 6month 12month
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
state: Fuenen
Study officials:
References: