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Completed

NCT Number: NCT01223625

Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function

The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.

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Key information

Conditions

Endothelial Dysfunction Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, Odense University Hospital

Odense, Fuenen, 5000, Denmark

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

Exclusion criteria

  • age below 18 or above 81 years
  • unconscious patients
  • serum creatinine > 176μmol/L
  • total-cholesterol > 7.0 mmol/l
  • hypothyreoidism ((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 5mg/day

Drug

Rosuvastatin 5mg/day

Other names: Crestor

Rosuvastatin 40mg/day

Drug

Rosuvastatin 40mg/day

Other names: Crestor

Primary outcomes

  1. The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.

    Time frame: One year

Secondary outcomes

  1. The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery

    Time frame: One Year

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Oct 19, 2010
Registry last updated
Oct 19, 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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