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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 21, 2014