Coronary Artery Bypass SurgeryPhase 4NCT01096875
Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery
A Phase 4 study testing Atorvastatin in people with Coronary Artery Bypass Surgery and Elective Surgical Procedure, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Artery Bypass Surgery, Elective Surgical Procedure
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2010to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective isolated coronary artery bypass surgery with on-pump technique
- Written informed consent
Who cannot join
- Concomitant valve or aortic surgery
- Left ventricular aneurysm repair
- Re-operation
- Emergency surgery
- History of myocardial infarction within less than 4 weeks
- Hepatic impairment
Show all 10Show fewer
- Chronic renal impairment
- Drug related side effects (allergy or hypersensitivity)
- Familial Hyperlipidemia
- Autoimmune conditions which require steroids
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical Faculty, Department of Cardiovascular Surgery
Ankara, Cebeci, 06340
About this study
Official title: Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Atorvastatin, Placebo
- Keywords
- Endothelial progenitor cells, Atorvastatin, Coronary surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Ator
40mg/day once daily for two weeks prior to surgery
PlaceboDrug
Also called Placebo tablets matched to atorvastatin
1tb/day once daily for two weeks prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Hydroxymethylglutaryl-CoA Reductase Inhibitors Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Atorvastatin like pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Progenitor Cells (EPCs) Count (Cells/µl)
Measured: Postoperative 6th hours
Secondary outcomes (3)
Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively
Measured: Change between statin and placebo groups at 30 days postoperatively
High Sensitive C-reactive Protein (hsCRP mg/L)
Measured: Postoperative 6th hours
High Sensitive C-reactive Protein (hsCRP mg/L)
Measured: 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Society of Hematology
- Responsible party
- Principal investigator, A. Ruchan Akar, Ankara University
- Investigators
- RUCHAN AKAR, Assoc. Prof., Study director, Ankara University Medical Faculty, Department of Cardiovascular Surgery Ankara, Turkey, 06340ONDER ASLAN, Prof., Study chair, Ankara University Medical Faculty, Department of Hematology Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096875
- Sponsor's protocol ID
- UMT0043
- Status last verified
- Jul 2014
- First submitted
- 16 Mar 2010
- Last updated
- 9 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22076751
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01096875
- Acronym / sponsor ID
- UMT0043
- Keywords
- Endothelial progenitor cells, Atorvastatin, Coronary surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Turkish Society of Hematology
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 9 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: AtorvastatinHydroxymethylglutaryl-CoA Reductase Inhibitors |
| Placebo | Placebo comparator | Drug: PlaceboAtorvastatin like pill |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective isolated coronary artery bypass surgery with on-pump technique
- Written informed consent
Key exclusion criteria (10 listed)
- Concomitant valve or aortic surgery
- Left ventricular aneurysm repair
- Re-operation
- Emergency surgery
- History of myocardial infarction within less than 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Ator40mg/day once daily for two weeks prior to surgery | Drug | Atorvastatin |
| PlaceboAlso: Placebo tablets matched to atorvastatin1tb/day once daily for two weeks prior to surgery | Drug | Placebo |
Primary outcome
Endothelial Progenitor Cells (EPCs) Count (Cells/µl)
Time frame: Postoperative 6th hours
3 secondary outcomes
Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively
Time frame: Change between statin and placebo groups at 30 days postoperatively
High Sensitive C-reactive Protein (hsCRP mg/L)
Time frame: Postoperative 6th hours
High Sensitive C-reactive Protein (hsCRP mg/L)
Time frame: 5 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22076751Baran 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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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RUCHAN AKAR, Assoc. Prof. study director
Ankara University Medical Faculty, Department of Cardiovascular Surgery Ankara, Turkey, 06340
ONDER ASLAN, Prof. study chair
Ankara University Medical Faculty, Department of Hematology Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Coronary Artery Bypass Surgery and Elective Surgical Procedure, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (time frame: Postoperative 6th hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.