Atrial FibrillationPhase 4NCT00287209
Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting. (RASCABG 1 Study)
A Phase 4 study testing Amiodarone in people with Atrial Fibrillation and Coronary Artery Bypass Grafting, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether postoperatively oral treatment with high dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the risk for development of atrial fibrillation after coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Bypass Grafting
- What is being tested?
- Amiodarone
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Aug 2005
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enlistment for an elective CABG
- age more than 18 years
- willingness to be randomised
- provision of informed consent
Who cannot join
- enlistment for other types of heart surgery
- earlier heart surgery
- resting heart rate below 40 bpm.
- AV-blockage of any degree
- preoperative atrial fibrillation or flutter
- former known atrial fibrillation or flutter lasting more than one month
Show all 11Show fewer
- hepatic dysfunction (ALAT > twice the upper normal limit)
- hyperthyroidism
- pregnancy
- breastfeeding
- known adverse reactions to amiodarone
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Skejby Sygehus, Aarhus University Hospital
Aarhus N, 8200
About this study
The purpose of this study is to determine whether postoperatively oral treatment with high dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the risk for development of atrial fibrillation after coronary artery bypass grafting.
Read the detailed description
New-onset atrial fibrillation (AF) after coronary bypass grafting (CABG) is common, with an incidence ranging from 5%-65%.
Although postoperative atrial tachyarrhythmia is often regarded as a temporary problem related to the operation and therefore innocuous, this complication has clinically significant adverse effects on patient outcome.
The purpose of this study was to find a good treatment without severe adverse effects to minimize the incidence of AF and maybe reduced the hemodynamic stress which AF is well known to cause. This would indicate that the risk of developing fatal events like cerebral apoplexy, TCI, AMI and death will be minimized as a result of the improved hemodynamic.
Overall AF is associated with risk of illness and for the development of severe complications as cerebral apoplexy, TCI, AMI and death with a factor 2-3.
There has furthermore been seen a twofold increase in the duration of intensive care unit stay and prolongation of the total hospitalization time with attendant increased hospitalization cost.
The outbreak of AF after CABG has been increasing over the last twenty years. It is speculated that the reason for this rise in incidence is due to the advancing age in the patient populations, more complex cardiac surgery as due to former underestimation of the arrhythmia.
Medical therapy includes various drugs, such as β-blockers, calcium channel blockers, digoxin, sotalol, quinidine, and amiodarone among others, to control heart rate and restore sinus rhythm. Most of these antiarrhythmic agents have significant cardiac and noncardiac adverse effects , why the use of these drugs should be minimized to a short period of time. Amiodarone is well known drug to treat AF and diminish the incidence of AF after CABG operation. So far there has not been any study focusing on postoperative high doses treatment with oral administrated amiodarone. The studies which have been publicized are studies where the drug was administrated intravenously pre-, post- or both pre- and postoperative. Some studies have orally administrated the drug in different regimes11 but no study has yet shown the possible affect of solitarily postoperative administrated high doses amiodarone after an intravenously administrated bolus, with the affect of getting loaded immediately.
- Being tested
- Amiodarone
- Keywords
- RASCABG 1 - study, Postoperative atrial fibrillation, Randomized, controlled trial, Amiodarone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Time to symptomatic atrial fibrillation, cerebral apoplexy/ transitory cerebral infarction (TCI), acute myocardial infarction (AMI), or death.
- Time to symptomatic or asymptomatic atrial fibrillation, cerebral apoplexy/TCI, AMI or death;
- Time to symptomatic or asymptomatic atrial fibrillation
- Time to symptomatic atrial fibrillation
All measured at postoperative day 7 and 30.
Secondary outcomes (3)
- Length of stay at Skejby Sygehus.
- Length of stay at Skejby Sygehus and local hospital.
- Length of stay at the intensive care unit (ICU) and intermediary unit, Skejby Sygehus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startJan 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Vibeke E Hjortdal, Professor, Principal investigator, Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287209
- Sponsor's protocol ID
- 2003 0245
- Status last verified
- Feb 2006
- First submitted
- 3 Feb 2006
- Last updated
- 6 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting. (RASCABG 1 Study)
- ClinicalTrials.gov ID
- NCT00287209
- Acronym / sponsor ID
- 2003 0245
- Keywords
- RASCABG 1 - study, Postoperative atrial fibrillation, Randomized, controlled trial, Amiodarone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Aug 2005
- First posted
- 6 Feb 2006 (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 postoperatively oral treatment with high dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the risk for development of atrial fibrillation after coronary artery bypass grafting.
Detailed description
New-onset atrial fibrillation (AF) after coronary bypass grafting (CABG) is common, with an incidence ranging from 5%-65%.
Although postoperative atrial tachyarrhythmia is often regarded as a temporary problem related to the operation and therefore innocuous, this complication has clinically significant adverse effects on patient outcome.
The purpose of this study was to find a good treatment without severe adverse effects to minimize the incidence of AF and maybe reduced the hemodynamic stress which AF is well known to cause. This would indicate that the risk of developing fatal events like cerebral apoplexy, TCI, AMI and death will be minimized as a result of the improved hemodynamic.
Overall AF is associated with risk of illness and for the development of severe complications as cerebral apoplexy, TCI, AMI and death with a factor 2-3.
There has furthermore been seen a twofold increase in the duration of intensive care unit stay and prolongation of the total hospitalization time with attendant increased hospitalization cost.
The outbreak of AF after CABG has been increasing over the last twenty years. It is speculated that the reason for this rise in incidence is due to the advancing age in the patient populations, more complex cardiac surgery as due to former underestimation of the arrhythmia.
Medical therapy includes various drugs, such as β-blockers, calcium channel blockers, digoxin, sotalol, quinidine, and amiodarone among others, to control heart rate and restore sinus rhythm. Most of these antiarrhythmic agents have significant cardiac and noncardiac adverse effects , why the use of these drugs should be minimized to a short period of time. Amiodarone is well known drug to treat AF and diminish the incidence of AF after CABG operation. So far there has not been any study focusing on postoperative high doses treatment with oral administrated amiodarone. The studies which have been publicized are studies where the drug was administrated intravenously pre-, post- or both pre- and postoperative. Some studies have orally administrated the drug in different regimes11 but no study has yet shown the possible affect of solitarily postoperative administrated high doses amiodarone after an intravenously administrated bolus, with the affect of getting loaded immediately.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- enlistment for an elective CABG
- age more than 18 years
- willingness to be randomised
- provision of informed consent
Key exclusion criteria (11 listed)
- enlistment for other types of heart surgery
- earlier heart surgery
- resting heart rate below 40 bpm.
- AV-blockage of any degree
- preoperative atrial fibrillation or flutter
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 |
|---|---|---|
| Amiodarone | Drug | – |
Primary outcome
- Time to symptomatic atrial fibrillation, cerebral apoplexy/ transitory cerebral infarction (TCI), acute myocardial infarction (AMI), or death.
- Time to symptomatic or asymptomatic atrial fibrillation, cerebral apoplexy/TCI, AMI or death;
- Time to symptomatic or asymptomatic atrial fibrillation
- Time to symptomatic atrial fibrillation
All measured at postoperative day 7 and 30.
3 secondary outcomes
- Length of stay at Skejby Sygehus.
- Length of stay at Skejby Sygehus and local hospital.
- Length of stay at the intensive care unit (ICU) and intermediary unit, Skejby Sygehus
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 6 Feb 2006.
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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.
Vibeke E Hjortdal, Professor principal investigator
Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
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 Amiodarone in people with Atrial Fibrillation and Coronary Artery Bypass Grafting, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 11 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 6 Feb 2006. 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 Denmark. 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.
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?
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?
- Time to symptomatic atrial fibrillation, cerebral apoplexy/ transitory cerebral infarction (TCI), acute myocardial infarction (AMI), or death.. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2006.