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| Name | Class |
|---|---|
| Turkish Society of Hematology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
|
| Placebo | Placebo Comparator | Atorvastatin like pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 40mg/day once daily for two weeks prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Progenitor Cells (EPCs) Count (Cells/µl) | Postoperative 6th hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Medical Faculty, Department of Cardiovascular Surgery | Ankara | Cebeci | 06340 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22076751 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery |
| FG001 | Placebo | Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery |
| BG001 | Placebo | Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endothelial Progenitor Cells (EPCs) Count (Cells/µl) | Posted | Mean | Standard Error | cells/µl | Postoperative 6th hours |
|
|
30 days postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin | Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low cardiac output | Cardiac disorders |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. A. Ruchan Akar MD., FRCS(CTh). | Ankara University Medical Faculty, Department of Cardiovascular Surgery | +90 533 646 06 84 | akarruchan@gmail.com |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| C000616511 | ORANGE protein, Arabidopsis |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | 1tb/day once daily for two weeks prior to surgery |
|
|
| High Sensitive C-reactive Protein (hsCRP mg/L) | 5 days postoperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively | Posted | Mean | Standard Deviation | percentage of LVEF | Change between statin and placebo groups at 30 days postoperatively |
|
|
|
| Secondary | High Sensitive C-reactive Protein (hsCRP mg/L) | Posted | Mean | Standard Error | mg/L | Postoperative 6th hours |
|
|
|
| Secondary | High Sensitive C-reactive Protein (hsCRP mg/L) | Posted | Mean | Standard Error | mg/L | 5 days postoperatively |
|
|
|
| 1 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery | 2 | 29 | 0 | 29 |
| Myocardial infarction | Cardiac disorders |
|
| Ventricular arrhythmia | Cardiac disorders |
|
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |