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
Results First Received: February 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Coronary Artery Bypass Surgery
Elective Surgical Procedure
Interventions: Drug: Atorvastatin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
  Hide More Information

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


No publications provided by Ankara University

Publications automatically indexed to this study:

Responsible Party: A. Ruchan Akar, Ankara University
ClinicalTrials.gov Identifier: NCT01096875     History of Changes
Other Study ID Numbers: UMT0043
Study First Received: March 16, 2010
Results First Received: February 10, 2013
Last Updated: July 4, 2014
Health Authority: Turkey: Ministry of Health