Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function

Phase 4

Completed

• Conditions: Endothelial Dysfunction; Atherosclerosis
• Interventions: Drug: Rosuvastatin 5mg/day; Drug: Rosuvastatin 40mg/day

• Registration Number: NCT01223625
• Lead Sponsor: Odense University Hospital

Brief Summary

The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-07
• Study Start: 2007-11
• Primary Completion: 2009-06
• Study Completion: 2010-06
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Last Update Submitted: 2010-10-18
• Study First Posted: 2010-10-19
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

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

Inclusion Criteria

1. STEMI
2. no prior treatment with statins

Exclusion Criteria

1. age below 18 or above 81 years
2. unconscious patients
3. serum creatinine > 176μmol/L
4. total-cholesterol > 7.0 mmol/l
5. hypothyreoidism ((TSH > 1.5 x ULN (upper limit of normal))
6. current liver disease (ALAT > 2 x ULN)
7. unexplained creatine kinase > 3 x ULN
8. alcohol or drug abuse within the last five years
9. prior myopathy or serious hypersensitivity reaction caused by statins
10. women with childbearing potential who were not using chemical or mechanical contraception
11. pregnant or breastfeeding women
12. history of malignancy unless a disease-free period of more than five years was present
13. patients with abnormal lung function test (LFT)
14. participation in another investigational drug study less than four weeks before enrolment in the present study
15. treatment with cyclosporine or fibrates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin 5mg/day	Rosuvastatin 5mg/day	Rosuvastatin 5mg/day
Rosuvastatin 40mg/day	Rosuvastatin 40mg/day	Rosuvastatin 40mg/day

Primary Outcome Measures

Name	Time	Method
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.	One year

Secondary Outcome Measures

Name	Time	Method
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery	One Year

Trial Locations

Locations (1)

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