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Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

This study has been completed.
Sponsor:
Collaborator:
Turkish Society of Hematology
Information provided by (Responsible Party):
A. Ruchan Akar, Ankara University
ClinicalTrials.gov Identifier:
NCT01096875
First received: March 16, 2010
Last updated: July 4, 2014
Last verified: July 2014

March 16, 2010
July 4, 2014
February 2010
July 2010   (final data collection date for primary outcome measure)
Endothelial Progenitor Cells (EPCs) Count (Cells/µl) [ Time Frame: Postoperative 6th hours ] [ Designated as safety issue: No ]
Endothelial Progenitor Cell Count [ Time Frame: Preoperative (24 hours prior to surgery), postoperative 6th hours, postoperative 5th day ] [ Designated as safety issue: No ]
Endothelial Progenitor Cell (EPC) Count
Complete list of historical versions of study NCT01096875 on ClinicalTrials.gov Archive Site
  • Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively [ Time Frame: Change between statin and placebo groups at 30 days postoperatively ] [ Designated as safety issue: No ]
  • High Sensitive C-reactive Protein (hsCRP mg/L) [ Time Frame: Postoperative 6th hours ] [ Designated as safety issue: No ]
  • High Sensitive C-reactive Protein (hsCRP mg/L) [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]
Clinical events [ Time Frame: Postoperatively 30 days ] [ Designated as safety issue: No ]
  1. Increase in left ventricular ejection fraction [Time Frame:30 days postoperatively]
  2. Major adverse cardiovascular events [Time Frame:30 days postoperatively]
  3. hsCRP [Time Frame: Postoperative 24 hours, 5 days]
Not Provided
Not Provided
 
Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery
Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Bypass Surgery
  • Elective Surgical Procedure
  • Drug: Atorvastatin
    40mg/day once daily for two weeks prior to surgery
    Other Name: Ator
  • Drug: Placebo
    1tb/day once daily for two weeks prior to surgery
    Other Name: Placebo tablets matched to atorvastatin
  • Active Comparator: Atorvastatin
    Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Atorvastatin like pill
    Intervention: Drug: Placebo
Baran Ç, Durdu S, Dalva K, Zaim Ç, Dogan A, Ocakoglu G, Gürman G, Arslan Ö, Akar AR. Effects of preoperative short term use of atorvastatin on endothelial progenitor cells after coronary surgery: a randomized, controlled trial. Stem Cell Rev. 2012 Sep;8(3):963-71. doi: 10.1007/s12015-011-9321-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01096875
UMT0043
Yes
A. Ruchan Akar, Ankara University
Ankara University
Turkish Society of Hematology
Study Director: RUCHAN AKAR, Assoc. Prof. Ankara University Medical Faculty, Department of Cardiovascular Surgery Ankara, Turkey, 06340
Study Chair: ONDER ASLAN, Prof. Ankara University Medical Faculty, Department of Hematology Ankara, Turkey
Ankara University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP