NCT01096875

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

July 9, 2014

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

March 16, 2010

Results QC Date

February 10, 2013

Last Update Submit

July 4, 2014

Conditions

Coronary Artery Bypass SurgeryElective Surgical Procedure

Keywords

Endothelial progenitor cellsAtorvastatinCoronary surgery

Outcome Measures

Primary Outcomes (1)

  • Endothelial Progenitor Cells (EPCs) Count (Cells/µl)

    Postoperative 6th hours

Secondary Outcomes (3)

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

    Change between statin and placebo groups at 30 days postoperatively

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

    Postoperative 6th hours

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

    5 days postoperatively

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Atorvastatin like pill

Drug: Placebo

Interventions

AtorvastatinDRUG

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

Also known as: Ator
Atorvastatin
PlaceboDRUG

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

Also known as: Placebo tablets matched to atorvastatin
Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective isolated coronary artery bypass surgery with on-pump technique
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical Faculty, Department of Cardiovascular Surgery

Ankara, Cebeci, 06340, Turkey (Türkiye)

Location

Related Publications (1)

  • Baran C, Durdu S, Dalva K, Zaim C, Dogan A, Ocakoglu G, Gurman G, Arslan O, Akar AR. Effects of preoperative short term use of atorvastatin on endothelial progenitor cells after coronary surgery: a randomized, controlled trial. Stem Cell Rev Rep. 2012 Sep;8(3):963-71. doi: 10.1007/s12015-011-9321-z.

    PMID: 22076751DERIVED

MeSH Terms

Interventions

AtorvastatinORANGE protein, Arabidopsis

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Limitations and Caveats

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.

Results Point of Contact

Title
Prof. A. Ruchan Akar MD., FRCS(CTh).
Organization
Ankara University Medical Faculty, Department of Cardiovascular Surgery
akarruchan@gmail.com
+90 533 646 06 84

Study Officials

  • RUCHAN AKAR, Assoc. Prof.

    Ankara University Medical Faculty, Department of Cardiovascular Surgery Ankara, Turkey, 06340

    STUDY DIRECTOR

  • ONDER ASLAN, Prof.

    Ankara University Medical Faculty, Department of Hematology Ankara, Turkey

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Consultant Cardiovascular Surgeon

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 31, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

July 9, 2014

Results First Posted

July 9, 2014

Record last verified: 2014-07

Locations

TU(1)