Original Query: ALL
Previous Study | Return to List | Next Study

Pleiotropic Effects of Atorvastatin in High Cardiovascular Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013103
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):
Dimitris Tousoulis, Hippocration General Hospital

Brief Summary:

The present study constitutes a study examining the effect of atorvastatin on vascular function in high cardiovascular risk patients. For this purpose the investigators will record atorvastatin effects on statin-naïve patients (patients that start statins treatment for first time). More specifically the investigators will study atorvastatin effects on:

  1. Endothelial function
  2. Arterial elastic properties
  3. Systemic Inflammatory/thrombotic mechanisms
  4. Vascular and myocardial redox state

Condition or disease Intervention/treatment Phase
Coronary Artery Disease HMG-CoA Reductase Inhibitor Toxicity Atherosclerosis Oxidative Stress Endothelial Dysfunction Drug: Atorvastatin, high vs low dose Drug: Atorvastatin vs Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Atorvastatin on Endothelial Function, Vascular and Myocardial Redox State in High Cardiovascular Risk Patients
Study Start Date : October 2007
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Atorvastatin, Ischemic Heart Disease 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).
Other Name: Atorvastatin high vs low dose in ischemic heart disease
Placebo Comparator: Atorvastatin vs Placebo Cardiac Surgery 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.
Other Name: Atorvastatin in Patients Undergoing Cardiac Surgery

Primary Outcome Measures :
  1. Vascular Nitric oxide bioavailability (Arm A + B) [ Time Frame: At the start and at the end of 2-week treatment period (arm A) and at the start and at the end of 3-day treatment period (arm B) ]

Secondary Outcome Measures :
  1. Vascular Redox state (Arm B) [ Time Frame: At the end of 3-day treatment period ]
  2. Myocardial redox state (Arm B) [ Time Frame: At the end of 3-day treatment period ]
  3. Systemic inflammatory, thrombotic and oxidative stress status (Arms A + B) [ Time Frame: At the start and at the end of 2-week treatment period (arm A) and at the start and at the end of 3-day treatment period (arm B) ]
  4. Vascular elastic properties (Arm A) [ Time Frame: At the start and at the end of 2-week treatment period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with coronary artery disease confirmed by coronary angiography.
  • Patients undergoing cardiac surgery such as elective coronary bypass artery grafting (CABG), valve replacement or aortic surgery.
  • All patients will not be under statins treatment for at least 6 months before their inclusion to the study.

Exclusion Criteria:

  • Acute coronary syndrome during the last 2 months
  • Renal failure (creatinine > 2,2 mg/dl)
  • Severe liver disease. Prospective follow-up of liver enzymes will be performed by the physicians in charge, as indicated by the relative guidelines regarding statins use and according to the current clinical practice.
  • Any chronic/acute inflammatory disease, autoimmune disease and/or cancer
  • Use of anti-inflammatory drugs or vitamins supplements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013103

Hippocration Hospital, Athens University Medical School
Athens, Attiki, Greece, 115 28
Sponsors and Collaborators
Hippocration General Hospital
Principal Investigator: Dimitris Tousoulis Professor, Athens University Medical School

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dimitris Tousoulis, Professor of Cardiology, Hippocration General Hospital Identifier: NCT01013103     History of Changes
Other Study ID Numbers: AT-1002009
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors