Coronary Artery BypassNCT00611143
Atorvastatin for Prevention of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
A study testing atorvastatin in people with Coronary Artery Bypass, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- consecutive patients scheduled for the elective off-pump CABG surgery
Who cannot join
- prior statin use
- previous episodes of atrial fibrillation
- impaired renal function with serum creatinine >2mg/dL
- serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- a malignancy or inflammatory disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cardiac and Vascular Center; Samsung Medical Center
Seoul, 135-710
About this study
Official title: The Effects of Atorvastatin on the Occurrence of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.
Read the detailed description
Atrial fibrillation after cardiac surgery is the most common arrhythmic complication that may increase incidence of congestive heart failure, renal insufficiency, and stroke, which increase the length of hospital stay, the rates of re-hospitalization, and cost of care. Its pathogenesis is multifactorial, and its prevention and management remain suboptimal. Recently, observational evidence has suggested that patients who have undergone previous statin therapy have a lower incidence of postoperative atrial fibrillation.
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.
- Conditions
- Coronary Artery Bypass
- Being tested
- atorvastatin
- Keywords
- Off-pump coronary artery bypass graft, Atorvastatin, Postoperative atrial fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
atorvastatin 20 mg/d, started 3 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Atorvastatin group Receives: Drug: atorvastatin |
| 2 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG
Measured: in-hospital period
Secondary outcomes (1)
major adverse cardiac and cerebrovascular events rate, including cardiovascular death, postoperative stroke, myocardial infarction, or persistent atrial fibrillation,and identification of predictive markers for postoperative atrial fibrillation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMay 2006
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Young Keun On, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611143
- Sponsor's protocol ID
- 2006-08-022
- Status last verified
- Jan 2008
- First submitted
- 27 Jan 2008
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Song YB, On YK, Kim JH, Shin DH, Kim JS, Sung J, Lee SH, Kim WS, Lee YT. The effects of atorvastatin on the occurrence of postoperative atrial fibrillation after off-pump coronary artery bypass grafting surgery. Am Heart J. 2008 Aug;156(2):373.e9-16. doi: 10.1016/j.ahj.2008.04.020. Epub 2008 Jun 17.
PubMed 18657672
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Atorvastatin on the Occurrence of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT00611143
- Acronym / sponsor ID
- 2006-08-022
- Conditions
- Coronary Artery Bypass
- Keywords
- Off-pump coronary artery bypass graft, Atorvastatin, Postoperative atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.
Detailed description
Atrial fibrillation after cardiac surgery is the most common arrhythmic complication that may increase incidence of congestive heart failure, renal insufficiency, and stroke, which increase the length of hospital stay, the rates of re-hospitalization, and cost of care. Its pathogenesis is multifactorial, and its prevention and management remain suboptimal. Recently, observational evidence has suggested that patients who have undergone previous statin therapy have a lower incidence of postoperative atrial fibrillation.
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: atorvastatinAtorvastatin group |
| 2 | No intervention | –Control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive patients scheduled for the elective off-pump CABG surgery
Key exclusion criteria (5 listed)
- prior statin use
- previous episodes of atrial fibrillation
- impaired renal function with serum creatinine >2mg/dL
- serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- a malignancy or inflammatory disease
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 |
|---|---|---|
| atorvastatinatorvastatin 20 mg/d, started 3 days before surgery | Drug | 1 |
Primary outcome
the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG
Time frame: in-hospital period
1 secondary outcome
major adverse cardiac and cerebrovascular events rate, including cardiovascular death, postoperative stroke, myocardial infarction, or persistent atrial fibrillation,and identification of predictive markers for postoperative atrial fibrillation
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2008.
- Derived from this study: PubMed 18657672Song YB, On YK, Kim JH, Shin DH, Kim JS, Sung J, Lee SH, Kim WS, Lee YT. The effects of atorvastatin on the occurrence of postoperative atrial fibrillation after off-pump coronary artery bypass grafting surgery. Am Heart J. 2008 Aug;156(2):373.e9-16. doi: 10.1016/j.ahj.2008.04.020. Epub 2008 Jun 17.
Related trials for Coronary Artery Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
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.
Young Keun On, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin in people with Coronary Artery Bypass, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 5 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 8 Feb 2008. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG (time frame: in-hospital period). 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 NCT00611143, 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 8 Feb 2008.