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Completed

NCT Number: NCT01096875

Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

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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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara University Medical Faculty, Department of Cardiovascular Surgery

Ankara, Cebeci, 06340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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

Other names: Ator

Placebo

Drug

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

Other names: Placebo tablets matched to atorvastatin

Primary outcomes

  1. Endothelial Progenitor Cells (EPCs) Count (Cells/µl)

    Time frame: Postoperative 6th hours

Secondary outcomes

  1. Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively

    Time frame: Change between statin and placebo groups at 30 days postoperatively

  2. High Sensitive C-reactive Protein (hsCRP mg/L)

    Time frame: Postoperative 6th hours

  3. High Sensitive C-reactive Protein (hsCRP mg/L)

    Time frame: 5 days postoperatively

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • Turkish Society of Hematology

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 31, 2010
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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