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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01245894
First received: November 22, 2010
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction [C14.907.585.500]
Drug: Low-dose Rosuvastatin
Drug: High-dose Rosuvastatin
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 the Coronary Microcirculation

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR). [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values. [ 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: Low-dose Rosuvastatin
5mg Rosuvastatin/day
Drug: Low-dose Rosuvastatin
Rosuvastatin 5mg/day for one year
Other Name: Crestor
Active Comparator: High-dose Rosuvastatin
Rosuvastatin 40mg/day
Drug: High-dose Rosuvastatin
Rosuvastatin 40mg/day for one year
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. 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01245894

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
  More Information

No publications provided

Responsible Party: MD Rasmus Egede, Department of Cardiology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01245894     History of Changes
Other Study ID Numbers: VF-20060
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
Index of microcirculatory resistance
Fractional Flow Reserve

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular 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 August 20, 2014