Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

Ankara University

Status and phase: Completed; Phase 4

Conditions: Elective Surgical Procedure; Coronary Artery Bypass Surgery

Treatments: Drug: Atorvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01096875

UMT0043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Atorvastatin like pill

Treatment:

Drug: Placebo