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Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01096875
First Posted: March 31, 2010
Last Update Posted: July 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Turkish Society of Hematology
Information provided by (Responsible Party):
A. Ruchan Akar, Ankara University
Results First Submitted: February 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Coronary Artery Bypass Surgery
Elective Surgical Procedure
Interventions: Drug: Atorvastatin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

Placebo

Atorvastatin like pill

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


Participant Flow:   Overall Study
    Atorvastatin   Placebo
STARTED   30   30 
COMPLETED   30   29 
NOT COMPLETED   0   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

Placebo

Atorvastatin like pill

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

Total Total of all reporting groups

Baseline Measures
   Atorvastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   22   21   43 
>=65 years   8   9   17 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.8  (8.6)   62.2  (8.1)   61.6  (8.4) 
Gender 
[Units: Participants]
     
Female   11   12   23 
Male   19   18   37 
Region of Enrollment 
[Units: Participants]
     
Turkey   30   30   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Endothelial Progenitor Cells (EPCs) Count (Cells/µl)   [ Time Frame: Postoperative 6th hours ]

2.  Secondary:   Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively   [ Time Frame: Change between statin and placebo groups at 30 days postoperatively ]

3.  Secondary:   High Sensitive C-reactive Protein (hsCRP mg/L)   [ Time Frame: Postoperative 6th hours ]

4.  Secondary:   High Sensitive C-reactive Protein (hsCRP mg/L)   [ Time Frame: 5 days postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The major limitation of this study is lack of functional assessment of EPCs using in vitro analysis of colony forming units because of the financial constraints.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. A. Ruchan Akar MD., FRCS(CTh).
Organization: Ankara University Medical Faculty, Department of Cardiovascular Surgery
phone: +90 533 646 06 84
e-mail: akarruchan@gmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: A. Ruchan Akar, Ankara University
ClinicalTrials.gov Identifier: NCT01096875     History of Changes
Other Study ID Numbers: UMT0043
First Submitted: March 16, 2010
First Posted: March 31, 2010
Results First Submitted: February 10, 2013
Results First Posted: July 9, 2014
Last Update Posted: July 9, 2014