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

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ClinicalTrials.gov Identifier: NCT01245894
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Infarction [C14.907.585.500] Drug: Low-dose Rosuvastatin Drug: High-dose Rosuvastatin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
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 the Coronary Microcirculation
Study Start Date : November 2007
Primary Completion Date : June 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR). [ Time Frame: One year ]

Secondary Outcome Measures :
  1. The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values. [ Time Frame: One year ]

Eligibility Criteria

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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. 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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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): 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

Responsible Party: MD Rasmus Egede, Department of Cardiology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01245894     History of Changes
Other Study ID Numbers: VF-20060
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2007

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 Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors