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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223625
• Other study ID #: VF-200600
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2010
• Last updated: October 18, 2010
• Start date: November 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2007
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Endothelial Dysfunction

Intervention

Drug:
• Rosuvastatin 5mg/day
Rosuvastatin 5mg/day
• Rosuvastatin 40mg/day
Rosuvastatin 40mg/day

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Odense University Hospital	Odense	Fuenen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.		One year	No
Secondary	The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery		One Year	No