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Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

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ClinicalTrials.gov Identifier: NCT01096875
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Collaborator:
Turkish Society of Hematology
Information provided by (Responsible Party):
A. Ruchan Akar, Ankara University

Study Description
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Brief Summary:
Experimental data have demonstrated favourable effects of statins on endothelial progenitor cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present prospective randomized controlled trial is to determine the effects of aggressive atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Surgery Elective Surgical Procedure Drug: Atorvastatin Drug: Placebo Phase 4

Detailed Description:
Endothelial progenitor cells, a subgroup of hematopoietic stem cells have a significant role in vascular homeostasis. In animal models of ischemia, endothelial progenitor cells are rapidly incorporated into sites of neovascularization, have the potential to induce and augment vasculogenesis/ angiogenesis, prevent cardiomyocyte apoptosis in peri-infarct regions, and reduce adverse remodeling. Treatment with atorvastatin has been shown to increase endothelial progenitor cell count in patients with coronary artery disease. Therefore, we will investigate whether atorvastatin augments the number of endothelial progenitor cells after cardiopulmonary bypass in patients undergoing coronary artery bypass surgery (CABG). Thus, we conducted a randomized double-blind, placebo-controlled, 2-way parallel trial in 60 patients undergoing coronary artery bypass surgery. Patients will receive either 2-week treatment with atorvastatin or placebo prior to surgery. Endothelial progenitor cells will be quantitated by flow cytometric phenotyping obtained from peripheral blood samples. In addition, cardiac markers (CK-MB mass, cardiac troponin-I), biochemical profile, liver function tests, high sensitive C-reactive protein (hsCRP) and coagulation profile will be determined at 4 time points: 1) preoperatively (baseline); 2) 6 hours after the end of cardiopulmonary bypass; 3) 24 hours after surgery; 4) 5th days postoperatively. Clinical, operative characteristics, cardiac markers, high sensitive C-reactive protein and endothelial progenitor cell count will be compared between the groups. Adverse outcomes will also be noted and reported.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Drug: Atorvastatin
40mg/day once daily for two weeks prior to surgery
Other Name: Ator
Placebo Comparator: Placebo
Atorvastatin like pill
 Drug: Placebo
1tb/day once daily for two weeks prior to surgery
Other Name: Placebo tablets matched to atorvastatin


Outcome Measures
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Primary Outcome Measures :
  1. Endothelial Progenitor Cells (EPCs) Count (Cells/µl) [ Time Frame: Postoperative 6th hours ]

Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively [ Time Frame: Change between statin and placebo groups at 30 days postoperatively ]
  2. High Sensitive C-reactive Protein (hsCRP mg/L) [ Time Frame: Postoperative 6th hours ]
  3. High Sensitive C-reactive Protein (hsCRP mg/L) [ Time Frame: 5 days postoperatively ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective isolated coronary artery bypass surgery with on-pump technique
  • Written informed consent

Exclusion Criteria:

  • Concomitant valve or aortic surgery
  • Left ventricular aneurysm repair
  • Re-operation
  • Emergency surgery
  • History of myocardial infarction within less than 4 weeks
  • Hepatic impairment
  • Chronic renal impairment
  • Drug related side effects (allergy or hypersensitivity)
  • Familial Hyperlipidemia
  • Autoimmune conditions which require steroids
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01096875


Locations
Turkey
Ankara University Medical Faculty, Department of Cardiovascular Surgery
Ankara, Cebeci, Turkey, 06340
Sponsors and Collaborators
Ankara University
Turkish Society of Hematology
Investigators
Study Director: RUCHAN AKAR, Assoc. Prof. Ankara University Medical Faculty, Department of Cardiovascular Surgery Ankara, Turkey, 06340
Study Chair: ONDER ASLAN, Prof. Ankara University Medical Faculty, Department of Hematology Ankara, Turkey
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: A. Ruchan Akar, Professor, Consultant Cardiovascular Surgeon, Ankara University
ClinicalTrials.gov Identifier: NCT01096875     History of Changes
Other Study ID Numbers: UMT0043
First Posted: March 31, 2010    Key Record Dates
Results First Posted: July 9, 2014
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by A. Ruchan Akar, Ankara University:
Endothelial progenitor cells
Atorvastatin
Coronary surgery

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors