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

NCT ID: NCT01245894

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction [C14.907.585.500]

Keywords

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Index of microcirculatory resistance Fractional Flow Reserve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Low-dose Rosuvastatin

5mg Rosuvastatin/day

Group Type ACTIVE_COMPARATOR

Low-dose Rosuvastatin

Intervention Type DRUG

Rosuvastatin 5mg/day for one year

High-dose Rosuvastatin

Rosuvastatin 40mg/day

Group Type ACTIVE_COMPARATOR

High-dose Rosuvastatin

Intervention Type DRUG

Rosuvastatin 40mg/day for one year

Interventions

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Low-dose Rosuvastatin

Rosuvastatin 5mg/day for one year

Intervention Type DRUG

High-dose Rosuvastatin

Rosuvastatin 40mg/day for one year

Intervention Type DRUG

Other Intervention Names

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Crestor Crestor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Cardiology, Odense University Hospital

Principal Investigators

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Rasmus Egede, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Odense University Hospital

Locations

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Department of Cardiology, Odense University Hospital

Odense, Fuenen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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VF-20060

Identifier Type: -

Identifier Source: org_study_id