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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203982

Enrollment

Registered

2010-09-17

Start date

2007-11-30

Completion date

2009-06-30

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-segment Elevation Myocardial Infarction, Subclinical Carotid Atherosclerosis

Keywords

CIMT, IVUS-VH, Coronary artery disease

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).

Interventions

DRUGRosuvastatin

Rosuvastatin 5mg/day for one year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 81 Years

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. -

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
changes from baseline in max CIMT	baseline, 6month, 12 month
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
change from baseline in max bulbus CIMT	baseline, 6month 12month

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026