The effect of intensive lipid lowering on markers of inflammation in patients with stable coronary artery disease. - Intensive lipid lowering
- Conditions
- Patients with cardiovascular risk factors and stable coronary artery disease, with a fasting total cholesterol level =5 mmol/l.
- Registration Number
- EUCTR2005-005084-29-GB
- Lead Sponsor
- Chief Scientitst Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Stable coronary artery disease
Patients aged 18-80 years
Total choleterol >5 mmol/l
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Acute coronary syndrome within 3 months
Previously documented statin-intolerance
Hepatic dysfunction (Childs Pugh score >5)
Significant comorbidity associated with reduce longevity
Participation in another clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether, compared to 10 mg atorvastatin, a strategy of intensive lipid lowering with 80 mg atorvastatin to LDL-cholesterol levels of =2 mmol/l has a significant net effect on i) platelet-monocyte binding, ii) monocyte phenotype and inflammatory function, iii) CD40-CD40ligand interactions, and iv) the balance of pro-and anti-inflammatory cytokines, chemokines and adhesion molecules.;Secondary Objective: To establish whether a linear relationship exists between lipid-lowering and the degree of anti-inflammatory effect.;Primary end point(s): Measures of inflammation and biomarkers at three months of randomised treatment
- Secondary Outcome Measures
Name Time Method