Phase 4
Completed N=60
Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery
Coronary Artery Bypass Surgery · Elective Surgical Procedure
Source: ClinicalTrials.gov NCT01096875 ↗
Enrolled (actual)
60
Serious AEs
5.1%
Results posted
Jul 2014
Primary outcomePrimary: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) — 5.00; 2.19 cells/µl
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Progenitor Cells (EPCs) Count (Cells/µl) |
5.00; 2.19 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively |
54.3; 53.2 | — |
| SECONDARY High Sensitive C-reactive Protein (hsCRP mg/L) |
4.3; 11.4 | — |
| SECONDARY High Sensitive C-reactive Protein (hsCRP mg/L) |
4.3; 11.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01096875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.