Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

Phase 4

Completed

Conditions: Elective Surgical Procedure
Coronary Artery Bypass Surgery

Interventions: Drug: Placebo
Drug: Atorvastatin

Registration Number: NCT01096875

Lead Sponsor: Ankara University

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Atorvastatin like pill
Atorvastatin	Atorvastatin	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Primary Outcome Measures

Name	Time	Method
Endothelial Progenitor Cells (EPCs) Count (Cells/µl)	Postoperative 6th hours

Secondary Outcome Measures

Name	Time	Method
High Sensitive C-reactive Protein (hsCRP mg/L)	5 days postoperatively
Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively	Change between statin and placebo groups at 30 days postoperatively