Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Bypass Surgery Elective Surgical Procedure |
Drug: Atorvastatin Drug: Placebo |
Phase 4 |
| 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 |
| Official Title: | Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial |
- Endothelial Progenitor Cell Count [ Time Frame: Postoperative 6th hours ] [ Designated as safety issue: No ]Endothelial Progenitor Cell (EPC) Count
- Clinical events [ Time Frame: Postoperatively 30 days ] [ Designated as safety issue: No ]
- Increase in left ventricular ejection fraction [Time Frame:30 days postoperatively]
- Major adverse cardiovascular events [Time Frame:30 days postoperatively]
- hsCRP [Time Frame: Postoperative 24 hours, 5 days]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
|
Drug: Atorvastatin
40mg/day once daily for two weeks prior to surgery
Other Name: Ator
|
|
Placebo Comparator: Placebo
Atorvastatin like pill
|
Drug: Placebo
1tb/day once daily for two weeks prior to surgery
Other Name: Placebo tablets matched to atorvastatin
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: RUCHAN A AKAR, Assoc.Prof. | +905336460684 | akarruchan@gmail.com |
| Contact: CAGDAS BARAN, MD | +905334697923 | cagdasbaran@gmail.com |
| Turkey | |
| Ankara University Medical Faculty, Department of Cardiovascular Surgery | Recruiting |
| Ankara, Cebeci, Turkey, 06340 | |
| Contact: AKAR RUCHAN, Assoc.Prof. +905336460684 akarruchan@gmail.com | |
| Contact: CAGDAS BARAN, MD +905334697923 cagdasbaran@gmail.com | |
| Principal Investigator: RUCHAN AKAR, Assoc.Prof. | |
| Principal Investigator: ONDER ASLAN, Prof. | |
| Sub-Investigator: CAGDAS BARAN, MD | |
| Sub-Investigator: SERKAN DURDU, MD | |
| Sub-Investigator: KLARA DALVA, MD | |
| Sub-Investigator: CAGIN ZAIM, MD | |
| Sub-Investigator: UMIT OZYURDA, Prof. | |
| Study Director: | RUCHAN AKAR, Assoc. Prof. | Ankara University Medical Faculty, Department of Cardiovascular Surgery Ankara, Turkey, 06340 |
| Study Chair: | ONDER ASLAN, Prof. | Ankara University Medical Faculty, Department of Hematology Ankara, Turkey |
More Information
No publications provided by Ankara University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assoc. Prof. A. Ruchan Akar / Ankara University, Ankara University, Department of Cardiovascular Surgery |
| ClinicalTrials.gov Identifier: | NCT01096875 History of Changes |
| Other Study ID Numbers: | UMT0043 |
| Study First Received: | March 16, 2010 |
| Last Updated: | April 13, 2010 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by Ankara University:
|
Endothelial progenitor cells Atorvastatin Coronary surgery |
Additional relevant MeSH terms:
|
Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013