Pleiotropic Effects of Atorvastatin in High Cardiovascular Risk Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitris Tousoulis, Hippocration General Hospital
ClinicalTrials.gov Identifier:
NCT01013103
First received: November 10, 2009
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hippocration General Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vascular Redox state (Arm B) [ Time Frame: At the end of 3-day treatment period ] [ Designated as safety issue: No ]
  • Myocardial redox state (Arm B) [ Time Frame: At the end of 3-day treatment period ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Vascular elastic properties (Arm A) [ Time Frame: At the start and at the end of 2-week treatment period ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013103

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

No publications provided by Hippocration General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dimitris Tousoulis, Professor of Cardiology, Hippocration General Hospital
ClinicalTrials.gov Identifier: NCT01013103     History of Changes
Other Study ID Numbers: AT-1002009
Study First Received: November 10, 2009
Last Updated: March 16, 2012
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on April 15, 2014