Atrial FibrillationNCT00654290
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft
A study testing Amiodarone + Propranolol, Amiodarone and Propranolol in people with Atrial Fibrillation, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for AF peri-CABG Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Amiodarone + Propranolol, Amiodarone and Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIran
- Study dates
- Mar 2007to Feb 2008
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who are going to have elective CABG
- Signing informed consent
Who cannot join
- EF<35%
- Bradycardia<60 per min
- Hypotension< 100 mmhg
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shiraz University of Medical Sciences/Cardiac Surgery and Cardiology Ward/Namazi and Shahid Faghihi Hospital
Shiraz, Fars, 71345
About this study
Official title: Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft, A Prospective Double-Blind Randomized Study
Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for AF peri-CABG
Read the detailed description
In this double blind randomized study 240 consecutive patients underwent elective coronary artery bypass grafting, being randomized prospectively into three groups, propranolol (p) (n=80), amiodarone (A) (n=80) and amiodarone with propranolol (AP) (n=80).
All groups received their medications from 7 days preoperatively and continued their medications for 5 days post CABG.
- Conditions
- Atrial Fibrillation
- Being tested
- Amiodarone + Propranolol, Amiodarone, Propranolol
- Keywords
- Atrial fibrillation, coronary bypass, Amiodarone, Propranolol, Coronary Artery Bypass Graft (CABG)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone + PropranololDrug
Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
AmiodaroneDrug
Amiodarone treated 7 days pre-operation to 5 days post CABG
PropranololDrug
Propranolol from 7 days pre-operation to 5 days post CABG
| Study group | Role | What they receive |
|---|---|---|
| P | Experimental | Propranolol from 7 days pre-operation to 5 days post CABG Receives: Drug: Propranolol |
| A | Active comparator | Amiodarone treated 7 days pre-operation to 5 days post CABG Receives: Drug: Amiodarone |
| AP | Active comparator | Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG Receives: Drug: Amiodarone + Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of atrial fibrillation post CABG
Measured: 7 days post CABG
Secondary outcomes (1)
bradycardia, mortality, hypotension, morbidity
Measured: 7 days post CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionFeb 2008
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 Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654290
- Sponsor's protocol ID
- 55318
- Other IDs
- NIH of IRAN
- Status last verified
- Apr 2008
- First submitted
- 2 Apr 2008
- Last updated
- 7 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kojuri J, Mahmoodi Y, Jannati M, Shafa M, Ghazinoor M, Sharifkazemi MB. Ability of amiodarone and propranolol alone or in combination to prevent post-coronary bypass atrial fibrillation. Cardiovasc Ther. 2009 Winter;27(4):253-8. doi: 10.1111/j.1755-5922.2009.00100.x.
PubMed 19903189
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft, A Prospective Double-Blind Randomized Study
- ClinicalTrials.gov ID
- NCT00654290
- Acronym / sponsor ID
- 55318
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, coronary bypass, Amiodarone, Propranolol, Coronary Artery Bypass Graft (CABG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 7 Apr 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.
Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for AF peri-CABG
Detailed description
In this double blind randomized study 240 consecutive patients underwent elective coronary artery bypass grafting, being randomized prospectively into three groups, propranolol (p) (n=80), amiodarone (A) (n=80) and amiodarone with propranolol (AP) (n=80).
All groups received their medications from 7 days preoperatively and continued their medications for 5 days post CABG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P | Experimental | Drug: PropranololPropranolol from 7 days pre-operation to 5 days post CABG |
| A | Active comparator | Drug: AmiodaroneAmiodarone treated 7 days pre-operation to 5 days post CABG |
| AP | Active comparator | Drug: Amiodarone + PropranololAmiodarone and Propranolol 7 days pre-operation to 5 days post CABG |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who are going to have elective CABG
- Signing informed consent
Key exclusion criteria (3 listed)
- EF<35%
- Bradycardia<60 per min
- Hypotension< 100 mmhg
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 + PropranololAmiodarone and Propranolol 7 days pre-operation to 5 days post CABG | Drug | AP |
| AmiodaroneAmiodarone treated 7 days pre-operation to 5 days post CABG | Drug | A |
| PropranololPropranolol from 7 days pre-operation to 5 days post CABG | Drug | P |
Primary outcome
incidence of atrial fibrillation post CABG
Time frame: 7 days post CABG
1 secondary outcome
bradycardia, mortality, hypotension, morbidity
Time frame: 7 days post CABG
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 7 Apr 2008.
- Derived from this study: PubMed 19903189Kojuri J, Mahmoodi Y, Jannati M, Shafa M, Ghazinoor M, Sharifkazemi MB. Ability of amiodarone and propranolol alone or in combination to prevent post-coronary bypass atrial fibrillation. Cardiovasc Ther. 2009 Winter;27(4):253-8. doi: 10.1111/j.1755-5922.2009.00100.x.
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amiodarone + Propranolol, Amiodarone and Propranolol in people with Atrial Fibrillation, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 3 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 7 Apr 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 Iran. 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?
incidence of atrial fibrillation post CABG (time frame: 7 days post CABG). 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 NCT00654290, 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 7 Apr 2008.