Back to resultsInfluence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
Primary Purpose
Myocardial Infarction [C14.907.585.500]
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Low-dose Rosuvastatin
High-dose Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction [C14.907.585.500] focused on measuring Index of microcirculatory resistance, Fractional Flow Reserve
Eligibility Criteria
Inclusion Criteria:
- ST-segment elevation myocardial infarction
- no prior treatment with statins and
- a non significant lesion in one of the two non-culprit coronary arteries
Exclusion Criteria:
- age below 18 or above 81 years,
- unconscious patients,
- serum creatinine > 176μmol/L,
- hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
- current liver disease (ALAT > 2 x ULN),
- unexplained creatine kinase > 3 x ULN,
- alcohol or drug abuse within the last five years,
- prior myopathy or serious hypersensitivity reaction caused by statins,
- women with childbearing potential who were not using chemical or mechanical contraception,
- pregnant or breastfeeding women,
- history of malignancy unless a disease-free period of more than five years was present,
- patients with abnormal lung function test (LFT),
- participation in another investigational drug study less than four weeks before enrolment in the present study,
- treatment with cyclosporine or fibrates
Sites / Locations
- Department of Cardiology, Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low-dose Rosuvastatin
High-dose Rosuvastatin
Arm Description
5mg Rosuvastatin/day
Rosuvastatin 40mg/day
Outcomes
Primary Outcome Measures
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
Secondary Outcome Measures
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
Full Information
NCT ID
NCT01245894
First Posted
November 22, 2010
Last Updated
November 22, 2010
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01245894
Brief Title
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
Official Title
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction [C14.907.585.500]
Keywords
Index of microcirculatory resistance, Fractional Flow Reserve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose Rosuvastatin
Arm Type
Active Comparator
Arm Description
5mg Rosuvastatin/day
Arm Title
High-dose Rosuvastatin
Arm Type
Active Comparator
Arm Description
Rosuvastatin 40mg/day
Intervention Type
Drug
Intervention Name(s)
Low-dose Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
Rosuvastatin 5mg/day for one year
Intervention Type
Drug
Intervention Name(s)
High-dose Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
Rosuvastatin 40mg/day for one year
Primary Outcome Measure Information:
Title
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
Time Frame
One year
Secondary Outcome Measure Information:
Title
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ST-segment elevation myocardial infarction
no prior treatment with statins and
a non significant lesion in one of the two non-culprit coronary arteries
Exclusion Criteria:
age below 18 or above 81 years,
unconscious patients,
serum creatinine > 176μmol/L,
hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
current liver disease (ALAT > 2 x ULN),
unexplained creatine kinase > 3 x ULN,
alcohol or drug abuse within the last five years,
prior myopathy or serious hypersensitivity reaction caused by statins,
women with childbearing potential who were not using chemical or mechanical contraception,
pregnant or breastfeeding women,
history of malignancy unless a disease-free period of more than five years was present,
patients with abnormal lung function test (LFT),
participation in another investigational drug study less than four weeks before enrolment in the present study,
treatment with cyclosporine or fibrates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmus Egede, MD
Organizational Affiliation
Department of Cardiology, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Odense University Hospital
City
Odense
State/Province
Fuenen
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
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Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
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