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

October 18, 2010 updated by: Odense University Hospital
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Fuenen
      • Odense, Fuenen, Denmark, 5000
        • Department of Cardiology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rosuvastatin 5mg/day
Drug: Rosuvastatin 5mg/day
Rosuvastatin 5mg/day
Other Names:
  • Crestor
ACTIVE_COMPARATOR: Rosuvastatin 40mg/day
Drug: Rosuvastatin 40mg/day
Rosuvastatin 40mg/day
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery
Time Frame: One Year
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Rasmus Egede, MD, Department of Cardiology, Odense University Hospital, Odense, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (ESTIMATE)

October 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 19, 2010

Last Update Submitted That Met QC Criteria

October 18, 2010

Last Verified

July 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VF-200600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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