Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

Coronary Artery Bypass Surgery Clinical Trial

Official title:

Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096875
• Other study ID #: UMT0043
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2010
• Last updated: July 4, 2014
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: July 2014
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery
• Elective Surgical Procedure

Intervention

Drug:
• Atorvastatin
40mg/day once daily for two weeks prior to surgery
• Placebo
1tb/day once daily for two weeks prior to surgery

Locations

Country	Name	City	State
Turkey	Ankara University Medical Faculty, Department of Cardiovascular Surgery	Ankara	Cebeci

Sponsors (2)

Lead Sponsor	Collaborator
Ankara University	Turkish Society of Hematology

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Progenitor Cells (EPCs) Count (Cells/µl)		Postoperative 6th hours	No
Secondary	Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively		Change between statin and placebo groups at 30 days postoperatively	No
Secondary	High Sensitive C-reactive Protein (hsCRP mg/L)		Postoperative 6th hours	No
Secondary	High Sensitive C-reactive Protein (hsCRP mg/L)		5 days postoperatively	No