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

Phase 4

Completed

• Conditions: Myocardial Infarction [C14.907.585.500]
• Interventions: Drug: High-dose Rosuvastatin; Drug: Low-dose Rosuvastatin

• Registration Number: NCT01245894
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-11
• Study Start: 2007-11
• Primary Completion: 2009-06
• Study Completion: 2010-06
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Last Update Submitted: 2010-11-22
• Study First Posted: 2010-11-23
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose Rosuvastatin	High-dose Rosuvastatin	Rosuvastatin 40mg/day
Low-dose Rosuvastatin	Low-dose Rosuvastatin	5mg Rosuvastatin/day

Primary Outcome Measures

Name	Time	Method
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).	One year

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.	One year

Trial Locations

Locations (1)

Department of Cardiology, Odense University Hospital; 🇩🇰 Odense, Fuenen, Denmark