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

Phase 4

Completed

• Conditions: ST-segment Elevation Myocardial Infarction; Subclinical Carotid Atherosclerosis
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01203982
• Lead Sponsor: Odense University Hospital

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).

Study Timeline

• Study Start: 2007-11
• Study Completion: 2009-06
• Status Verified: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-16
• Last Update Submitted: 2010-09-16
• Study First Posted: 2010-09-17
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin 5mg	Rosuvastatin	Rosuvastatin 5mg/day
Rosuvastatin 40mg	Rosuvastatin	Rosuvastatin 40mg/day

Primary Outcome Measures

Name	Time	Method
change from baseline in mean CIMT	baseline, 6month, 12 month	Average of the far wall of common and bulbus carotid artery

Secondary Outcome Measures

Name	Time	Method
changes from baseline in max CIMT	baseline, 6month, 12 month
change from baseline in mean common CIMT	baaseline, 6month 12 month
change from baseline in max common CIMT	baseline, 6month 12month
change from baseline in mean bulbus CIMT	Baseline, 6month 12 month
change from baseline in max bulbus CIMT	baseline, 6month 12month
change from baseline in lipid values	baseline, 6month 12month
correlation between CIMT measurements and lipid values	Baseline, 6month 12 month
correlation between CIMT measurements and plaque components evaluated by IVUS-VH	Baseline, 6month 12month

Trial Locations

Locations (1)

Department of Cardiology, Odense University Hospital; 🇩🇰 Odense, Fuenen, Denmark