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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223625
First Posted: October 19, 2010
Last Update Posted: October 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital
  Purpose
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.

Condition Intervention Phase
Endothelial Dysfunction Atherosclerosis Drug: Rosuvastatin 5mg/day Drug: Rosuvastatin 40mg/day Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery. [ Time Frame: One year ]

Secondary Outcome Measures:
  • The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery [ Time Frame: One Year ]

Enrollment: 87
Study Start Date: November 2007
Study Completion Date: June 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rosuvastatin 5mg/day
Rosuvastatin 5mg/day
Drug: Rosuvastatin 5mg/day
Rosuvastatin 5mg/day
Other Name: Crestor
Active Comparator: Rosuvastatin 40mg/day
Rosuvastatin 40mg/day
Drug: Rosuvastatin 40mg/day
Rosuvastatin 40mg/day
Other Name: Crestor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. STEMI
  2. no prior treatment with statins

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. hypothyreoidism ((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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223625


Locations
Denmark
Department of Cardiology, Odense University Hospital
Odense, Fuenen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Rasmus Egede, MD Department of Cardiology, Odense University Hospital, Odense, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rasmus Egede, Department of Cardiology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01223625     History of Changes
Other Study ID Numbers: VF-200600
First Submitted: October 18, 2010
First Posted: October 19, 2010
Last Update Posted: October 19, 2010
Last Verified: July 2007

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors