Patients With Coronary Artery Disease Scheduled for by Pass SurgeryEarly Phase 1NCT01955759
Atrial Fibrillation and By-pass Surgery
A Early Phase 1 study testing Amiodarone tab 200 mg x 3, rosuvastatin 20 mg tab x1 and beta blockers Bisoprolol in adjusted dose in people with Patients With Coronary Artery Disease Scheduled for by Pass Surgery, run by Heart Center BH Tuzla at 1 site in Bosnia and Herzegovina.
Trial summary
The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Coronary Artery Disease Scheduled for by Pass Surgery
- What is being tested?
- Amiodarone tab 200 mg x 3, rosuvastatin 20 mg tab x1 and beta blockers Bisoprolol in adjusted dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- Dec 2013to Feb 2015
- Phase
- Early Phase 1
- 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
- significant coronary disease, sinus rhythm
Who cannot join
- valvular disease, former by-pass surgery
Trial locations and contacts
1 site in 1 country.
Goran Imamovic contact
Bosnia and Herzegovina1 site
Heart Center BH
Tuzla, TK, 75000
Enes Osmanović, +387 66 725 744, osmanovic@bih.net.ba
About this study
Official title: Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery
The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery.
- Being tested
- Amiodarone tab 200 mg x 3, rosuvastatin 20 mg tab x1, beta blockers Bisoprolol in adjusted dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone tab 200 mg x 3Drug
Also called cordarone
starting 7 days before coronary by-pass surgery per os 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge
rosuvastatin 20 mg tab x1Drug
Also called crestor
starting 7 days before coronary by-pass surgery
beta blockers Bisoprolol in adjusted doseDrug
Also called zebeta
starting 7 days befoe coronary by-pass surgery
| Study group | Role | What they receive |
|---|---|---|
| beta blocker and amiodarone | Experimental | The inteventin will be that patients will receive beta blocker Bisoprolol in adjusted dose + Amiodarone per os starting 7 days before coronary by-pass surgery, 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge Receives: Drug: Amiodarone tab 200 mg x 3; Drug: beta blockers Bisoprolol in adjusted dose |
| beta blocker and statin | Experimental | The intervention will be that patients will receive beta blocker (Bisoprolol tab in adjusted dose)+ Rosuvastatin 20 mg. x 1 starting 7 days before coronary by-pass surgry untill discharge. Receives: Drug: rosuvastatin 20 mg tab x1; Drug: beta blockers Bisoprolol in adjusted dose |
| beta blocker | Placebo comparator | Patients will receive beta blocker (Bisoprolol tab in adjusted dose). Receives: Drug: beta blockers Bisoprolol in adjusted dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation
outcome will be number of patients free from atrial fibrillation.
Measured: 10 days on average during hospital stay after coronary by-pass surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Coronary Artery Disease Scheduled for by Pass SurgeryStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center BH Tuzla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enes Osmanović, Heart Center BH Tuzla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955759
- Sponsor's protocol ID
- 0115/09 - (2013)
- Status last verified
- Dec 2013
- First submitted
- 21 Sep 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery
- ClinicalTrials.gov ID
- NCT01955759
- Acronym / sponsor ID
- 0115/09 - (2013)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Heart Center BH TuzlaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 7 Oct 2013 (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 aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| beta blocker and amiodarone | Experimental | Drug: Amiodarone tab 200 mg x 3, Drug: beta blockers Bisoprolol in adjusted doseThe inteventin will be that patients will receive beta blocker Bisoprolol in adjusted dose + Amiodarone per os starting 7 days before coronary by-pass surgery, 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge |
| beta blocker and statin | Experimental | Drug: rosuvastatin 20 mg tab x1, Drug: beta blockers Bisoprolol in adjusted doseThe intervention will be that patients will receive beta blocker (Bisoprolol tab in adjusted dose)+ Rosuvastatin 20 mg. x 1 starting 7 days before coronary by-pass surgry untill discharge. |
| beta blocker | Placebo comparator | Drug: beta blockers Bisoprolol in adjusted dosePatients will receive beta blocker (Bisoprolol tab in adjusted dose). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- significant coronary disease, sinus rhythm
Key exclusion criteria (1 listed)
- valvular disease, former by-pass surgery
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 tab 200 mg x 3Also: cordaronestarting 7 days before coronary by-pass surgery per os 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge | Drug | beta blocker and amiodarone |
| rosuvastatin 20 mg tab x1Also: crestorstarting 7 days before coronary by-pass surgery | Drug | beta blocker and statin |
| beta blockers Bisoprolol in adjusted doseAlso: zebetastarting 7 days befoe coronary by-pass surgery | Drug | beta blocker, beta blocker and amiodarone, beta blocker and statin |
Primary outcome
atrial fibrillation
Time frame: 10 days on average during hospital stay after coronary by-pass surgery
outcome will be number of patients free from atrial fibrillation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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.
Goran Imamovic contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amiodarone tab 200 mg x 3, rosuvastatin 20 mg tab x1 and beta blockers Bisoprolol in adjusted dose in people with Patients With Coronary Artery Disease Scheduled for by Pass Surgery, run by Heart Center BH Tuzla at 1 site in Bosnia and Herzegovina.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Dec 2013. 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 Bosnia and Herzegovina. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enes Osmanovic, Master's degree (+387 66 725 744, osmanovic@bhsrce.ba), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation (time frame: 10 days on average during hospital stay after coronary by-pass surgery). 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 17 Dec 2013.