Atrial FibrillationPhase 4PASCARTNCT00724581
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer
A Phase 4 study testing Amiodarone in people with Atrial Fibrillation, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation. A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Amiodarone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Dec 2009
- 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
- Resection of the lung due to confirmed diagnosis of cancer pulmones.
- Elective operation (scheduled operation for at least one day)
- Ready to be randomized
- Patient must be at least 18 at time of operation
Who cannot join
- Former operation of the lung
- Former heart surgery
- Bradycardia below 40 beats/ min
- Hypotension with systolic blood pressure below 80 mmHg
- AV-blockage of any degree or sick sinus node
- QTc interval above 440 ms for men or above 460 ms for women
Show all 13Show fewer
- Paroxysmal, persistent or permanent atrial fibrillation or flutter
- Former atrial fibrillation or flutter for more than a month.
- Pregnant or positive pregnancy test
- Breastfeeding
- ALAT of more than twice the normal over limit
- Treatment with monoamineoxidase inhibitors (MAOI)
- Allergy to one or more components in amiodarone
Trial locations and contacts
1 site in 1 country.
Thomas Decker, MD contact
Denmark1 site
Aarhus University Hospital, Skejby
Aarhus, DK-8200
Lars R Zebis, MD, Ph.D., +45 89495566, lrz@post.tele.dk
Thomas D Christensen, MD, Ph.D., +45 89495566
About this study
Official title: Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation.
A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period.
Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.
Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.
- Conditions
- Atrial Fibrillation
- Being tested
- Amiodarone
- Keywords
- Atrial fibrillation, 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
intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free of atrial fibrillation
Measured: 31082009
Secondary outcomes (1)
Cost-benefit analysis of amiodarone prophylactic
Measured: 31082009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
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 Aarhus University HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lars R Zebis, MD, Ph.D., Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724581
- Sponsor's protocol ID
- 2612-3681
- Acronym
- PASCART
- Status last verified
- Jul 2008
- First submitted
- 25 Jul 2008
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
- ClinicalTrials.gov ID
- NCT00724581
- Acronym / sponsor ID
- PASCART / 2612-3681
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, amiodarone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 29 Jul 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.
Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation.
A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period.
Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.
Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Amiodarone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resection of the lung due to confirmed diagnosis of cancer pulmones.
- Elective operation (scheduled operation for at least one day)
- Ready to be randomized
- Patient must be at least 18 at time of operation
Key exclusion criteria (13 listed)
- Former operation of the lung
- Former heart surgery
- Bradycardia below 40 beats/ min
- Hypotension with systolic blood pressure below 80 mmHg
- AV-blockage of any degree or sick sinus node
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 |
|---|---|---|
| Amiodaroneintravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days | Drug | A |
Primary outcome
Free of atrial fibrillation
Time frame: 31082009
1 secondary outcome
Cost-benefit analysis of amiodarone prophylactic
Time frame: 31082009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Thomas Decker, MD contact
Lars R Zebis, MD, Ph.D. principal investigator
Aarhus University Hospital Skejby
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, run by Aarhus University Hospital 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 13 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 29 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars R Zebis, MD (+45 89495566, lrz@post.tele.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free of atrial fibrillation (time frame: 31082009). 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 29 Jul 2008.