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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:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01223625
First received: October 18, 2010
Last updated: NA
Last verified: July 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery [ Time Frame: One Year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Odense University Hospital

Additional 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
Study First Received: October 18, 2010
Last Updated: October 18, 2010
Health Authority: Denmark: The Danish Medicines Agency

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

ClinicalTrials.gov processed this record on May 23, 2013