Pleiotropic Effects of Atorvastatin in High Cardiovascular Risk Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Coronary Artery DiseaseHMG-CoA Reductase Inhibitor ToxicityAtherosclerosisOxidative StressEndothelial Dysfunction
Interventions
DRUG

Atorvastatin, high vs low dose

In this arm patients with ischemic heart disease will be recruited. In a double-blind crossover design heart failure patients (n=30) naïve to statins treatment will be randomized to receive oral atorvastatin 10mg/day 1x1(n=15) or oral atorvastatin 40mg/day 1x1 (n=15) for 4 weeks. At the end of 4 weeks a 2-week wash out period will follow and then all patients will switch atorvastatin dose and continue treatment for 4 weeks (e.g all patients that were under atorvastatin 10mg/day will be switched to atorvastatin 40mg/day and vice versa).

DRUG

Atorvastatin vs Placebo

In this arm, patients undergoing cardiac surgery (CABG, valve replacement or aortic surgery) that are not under statins treatment will be recruited. Patients will be randomized in a double-blind fashion to atorvastatin 40mg/day or placebo for 3 days before surgery date.

Trial Locations (1)

115 28

Hippocration Hospital, Athens University Medical School, Athens

All Listed Sponsors
lead

Hippocration General Hospital

OTHER

NCT01013103 - Pleiotropic Effects of Atorvastatin in High Cardiovascular Risk Patients | Biotech Hunter | Biotech Hunter