Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Bypass Surgery Elective Surgical Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

40mg/day once daily for two weeks prior to surgery

Placebo

Atorvastatin like pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1tb/day once daily for two weeks prior to surgery

Interventions

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Atorvastatin

40mg/day once daily for two weeks prior to surgery

Intervention Type DRUG

Placebo

1tb/day once daily for two weeks prior to surgery

Intervention Type DRUG

Other Intervention Names

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Ator Placebo tablets matched to atorvastatin

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No