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Completed

NCT Number: NCT01203982

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • STEMI,
  • no prior treatment with statins and
  • a non significant lesion in one of the two non-culprit coronary arteries. -

Exclusion criteria

  • age below 18 or above 81 years,
  • unconscious patients,
  • serum creatinine > 176μmol/L,
  • total-cholesterol > 7.0 mmol/l,
  • hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
  • current liver disease (ALAT > 2 x ULN),
  • unexplained creatine kinase > 3 x ULN,
  • alcohol or drug abuse within the last five years,
  • prior myopathy or serious hypersensitivity reaction caused by statins,
  • women with childbearing potential who were not using chemical or mechanical contraception,
  • pregnant or breastfeeding women,
  • history of malignancy unless a disease-free period of more than five years was present,
  • patients with abnormal lung function test (LFT),
  • participation in another investigational drug study less than four weeks before enrolment in the present study,
  • treatment with cyclosporine or fibrates. -

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 5mg/day for one year

Other names: Crestor

Primary outcomes

  1. change from baseline in mean CIMT

    Time frame: baseline, 6month, 12 month

    Average of the far wall of common and bulbus carotid artery

Secondary outcomes

  1. changes from baseline in max CIMT

    Time frame: baseline, 6month, 12 month

  2. change from baseline in mean common CIMT

    Time frame: baaseline, 6month 12 month

  3. change from baseline in max common CIMT

    Time frame: baseline, 6month 12month

  4. change from baseline in mean bulbus CIMT

    Time frame: Baseline, 6month 12 month

  5. change from baseline in max bulbus CIMT

    Time frame: baseline, 6month 12month

  6. change from baseline in lipid values

    Time frame: baseline, 6month 12month

  7. correlation between CIMT measurements and lipid values

    Time frame: Baseline, 6month 12 month

  8. correlation between CIMT measurements and plaque components evaluated by IVUS-VH

    Time frame: Baseline, 6month 12month

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2009
First posted
Sep 17, 2010
Registry last updated
Sep 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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