Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment

November 22, 2010 updated by: Odense University Hospital

Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation

The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.

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. ST-segment elevation myocardial infarction
  2. no prior treatment with statins and
  3. a non significant lesion in one of the two non-culprit coronary arteries

Exclusion Criteria:

  1. age below 18 or above 81 years,
  2. unconscious patients,
  3. serum creatinine > 176μmol/L,
  4. hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
  5. current liver disease (ALAT > 2 x ULN),
  6. unexplained creatine kinase > 3 x ULN,
  7. alcohol or drug abuse within the last five years,
  8. prior myopathy or serious hypersensitivity reaction caused by statins,
  9. women with childbearing potential who were not using chemical or mechanical contraception,
  10. pregnant or breastfeeding women,
  11. history of malignancy unless a disease-free period of more than five years was present,
  12. patients with abnormal lung function test (LFT),
  13. participation in another investigational drug study less than four weeks before enrolment in the present study,
  14. 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-dose Rosuvastatin
5mg Rosuvastatin/day
Drug: Low-dose Rosuvastatin
Rosuvastatin 5mg/day for one year
Other Names:
  • Crestor
Active Comparator: High-dose Rosuvastatin
Rosuvastatin 40mg/day
Drug: High-dose Rosuvastatin
Rosuvastatin 40mg/day for one year
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
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

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

November 22, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VF-20060

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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