Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2007
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedNovember 23, 2010
November 1, 2007
1.6 years
November 22, 2010
November 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
One year
Secondary Outcomes (1)
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
One year
Study Arms (2)
Low-dose Rosuvastatin
ACTIVE COMPARATOR5mg Rosuvastatin/day
High-dose Rosuvastatin
ACTIVE COMPARATORRosuvastatin 40mg/day
Interventions
Rosuvastatin 5mg/day for one year
Rosuvastatin 40mg/day for one year
Eligibility Criteria
You may qualify if:
- ST-segment elevation myocardial infarction
- no prior treatment with statins and
- a non significant lesion in one of the two non-culprit coronary arteries
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Odense University Hospital
Odense, Fuenen, 5000, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rasmus Egede, MD
Department of Cardiology, Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 22, 2010
First Posted
November 23, 2010
Study Start
November 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2010
Last Updated
November 23, 2010
Record last verified: 2007-11