Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery - Full Text View

Purpose

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	Intervention	Phase
Coronary Artery Bypass Surgery Elective Surgical Procedure	Drug: Atorvastatin Drug: Placebo	Phase 4


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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery

Drug Information available for: Atorvastatin Atorvastatin calcium Atorvastatin calcium trihydrate

U.S. FDA Resources

Further study details as provided by Ankara University:

Primary Outcome Measures:

Endothelial Progenitor Cells (EPCs) Count (Cells/µl) [ Time Frame: Postoperative 6th hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively [ Time Frame: Change between statin and placebo groups at 30 days postoperatively ] [ Designated as safety issue: No ]
High Sensitive C-reactive Protein (hsCRP mg/L) [ Time Frame: Postoperative 6th hours ] [ Designated as safety issue: No ]
High Sensitive C-reactive Protein (hsCRP mg/L) [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]


Enrollment:	60
Study Start Date:	February 2010
Study Completion Date:	October 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

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: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baran Ç, Durdu S, Dalva K, Zaim Ç, Dogan A, Ocakoglu G, Gürman G, Arslan Ö, Akar AR. Effects of preoperative short term use of atorvastatin on endothelial progenitor cells after coronary surgery: a randomized, controlled trial. Stem Cell Rev. 2012 Sep;8(3):963-71. doi: 10.1007/s12015-011-9321-z.


Responsible Party:	A. Ruchan Akar, Professor, Consultant Cardiovascular Surgeon, Ankara University
ClinicalTrials.gov Identifier:	NCT01096875 History of Changes
Other Study ID Numbers:	UMT0043
Study First Received:	March 16, 2010
Results First Received:	February 10, 2013
Last Updated:	July 4, 2014
Health Authority:	Turkey: Ministry of Health

Keywords provided by Ankara University:


Endothelial progenitor cells Atorvastatin Coronary surgery

Additional relevant MeSH terms:


Atorvastatin Calcium Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents	Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016