Atrial FibrillationPhase 3NCT01817439
Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity. Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at high risk for phlebitis. 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
- 104 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to May 2015
- Phase
- Phase 3
- 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
- Over 18 years of age,
- Patients who will be admitted to the ICCU / ICU wards
- Patients with recent onset of atrial fibrillation (duration < 48h).
Who cannot join
- Age < 18 years
- Baseline systolic blood pressure < 100 mm/hg
- Known thyroid disease
- Serum potassium < 3.5 mmol/l
- Pretreatment with amiodarone
- Pregnant or lactating women.
- Participation in other clinical trial.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Western Galilee Hospital
Nahariya, Israel, 972
Lilach Shema-didi, PhD, 507887538 ext. 972, lilach.shema-didi@naharia.health.gov.il
About this study
Official title: The Effect of Intravenous vs. Oral Administration of Amiodarone on the Incidence Rate of Phlebitis Among Patients With Recent Onset of Atrial Fibrillation (AF)
Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity. Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention, delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research goal.
Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the treatment of AF of recent onset (duration < 48 h).
Read the detailed description
Atrial fibrillation (AF) is the most common heart rhythm abnormality worldwide. Three therapeutic goals should be considered for each patient: Rate control, maintenance of sinus rhythm and prevention of thromboembolism. In managing AF, numerous antiarrhythmic drugs have been used. Intravenous amiodarone is a class III antiarrhythmic agent which has been reported to be safe and most effective in various clinical settings, without an associated increase in mortality rate. In most of the cases, the method of administration is via peripheral infusion. Phlebitis is the most common complication with peripheral infusion of amiodarone. Phlebitis adversely affects patient care; it may interfere with the continued infusion of amiodarone, necessitate insertion of another peripheral intravenous or central catheter, and extend hospitalization. Furthermore, patients who develop phlebitis, experience pain, swelling, and inflammation. Phlebitis can be prevented by oral administration.
The goal of the proposed study is to evaluate the incidence rate of phlebitis following IV administration of amiodarone and to investigate whether the oral administration of amiodarone in patients with recent onset AF (duration < 48 h), is safer than, and as efficient as, the IV administration of the same drug in the ICCU and ICU setting.
- Conditions
- Atrial Fibrillation
- Being tested
- Amiodarone
- Keywords
- oral Amiodarone, IV Amiodarone, phlebitis, thrombophlebitis, adverse events
- Medical subject headings
- Atrial Fibrillation, Phlebitis, Thrombophlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
Also called Procor
patients will be randomly assigned to oral OR IV Amiodarone
| Study group | Role | What they receive |
|---|---|---|
| oral amiodarone, group A | Experimental | oral amiodarone 400 mg three times a day for 2 days Receives: Drug: Amiodarone |
| IV amiodarone, Group B | Experimental | Amiodarone:
IV loading of 300 mg for 30 min in 100cc glucose 5% IV infusion with 900 mg/24h in 1000cc glucose 5% Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of phlebitis
For detection of eventual amiodarone induced phlebitis the site of venous access will be examined 30 min, 3, 6, 12, 24 h after drug administration by one of the investigators
Measured: during 24 h
Secondary outcomes (2)
incidence of hypotension
blood pressure measurements will be taken on admission and during treatment at defined intervals of 3, 6, 12, 18 and 24 h
Measured: during 24 h
Cumulative incidence of restored sinus rhythm
Patients will be monitored during all stuffy period
Measured: During 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, lilach shema, Western Galilee Hospital-Nahariya
- Investigators
- Atar Shaul, MD, Principal investigator, Western Galilee HospitalNicola Makhoul, MD, Principal investigator, Western Galilee HospitalLilach Shema-didi, PhD, Principal investigator, Western Galilee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817439
- Sponsor's protocol ID
- AP 1
- Status last verified
- Mar 2013
- First submitted
- 18 Mar 2013
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous vs. Oral Administration of Amiodarone on the Incidence Rate of Phlebitis Among Patients With Recent Onset of Atrial Fibrillation (AF)
- ClinicalTrials.gov ID
- NCT01817439
- Acronym / sponsor ID
- AP 1
- Conditions
- Atrial Fibrillation
- Keywords
- oral Amiodarone, IV Amiodarone, phlebitis, thrombophlebitis, adverse events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 25 Mar 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.
Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity. Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention, delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research goal.
Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the treatment of AF of recent onset (duration < 48 h).
Detailed description
Atrial fibrillation (AF) is the most common heart rhythm abnormality worldwide. Three therapeutic goals should be considered for each patient: Rate control, maintenance of sinus rhythm and prevention of thromboembolism. In managing AF, numerous antiarrhythmic drugs have been used. Intravenous amiodarone is a class III antiarrhythmic agent which has been reported to be safe and most effective in various clinical settings, without an associated increase in mortality rate. In most of the cases, the method of administration is via peripheral infusion. Phlebitis is the most common complication with peripheral infusion of amiodarone. Phlebitis adversely affects patient care; it may interfere with the continued infusion of amiodarone, necessitate insertion of another peripheral intravenous or central catheter, and extend hospitalization. Furthermore, patients who develop phlebitis, experience pain, swelling, and inflammation. Phlebitis can be prevented by oral administration.
The goal of the proposed study is to evaluate the incidence rate of phlebitis following IV administration of amiodarone and to investigate whether the oral administration of amiodarone in patients with recent onset AF (duration < 48 h), is safer than, and as efficient as, the IV administration of the same drug in the ICCU and ICU setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral amiodarone, group A | Experimental | Drug: Amiodaroneoral amiodarone 400 mg three times a day for 2 days |
| IV amiodarone, Group B | Experimental | Drug: AmiodaroneAmiodarone: IV loading of 300 mg for 30 min in 100cc glucose 5% IV infusion with 900 mg/24h in 1000cc glucose 5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age,
- Patients who will be admitted to the ICCU / ICU wards
- Patients with recent onset of atrial fibrillation (duration < 48h).
Key exclusion criteria (7 listed)
- Age < 18 years
- Baseline systolic blood pressure < 100 mm/hg
- Known thyroid disease
- Serum potassium < 3.5 mmol/l
- Pretreatment with amiodarone
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 |
|---|---|---|
| AmiodaroneAlso: Procorpatients will be randomly assigned to oral OR IV Amiodarone | Drug | IV amiodarone, Group B, oral amiodarone, group A |
Primary outcome
Incidence rate of phlebitis
Time frame: during 24 h
For detection of eventual amiodarone induced phlebitis the site of venous access will be examined 30 min, 3, 6, 12, 24 h after drug administration by one of the investigators
2 secondary outcomes
incidence of hypotension
Time frame: during 24 h
Cumulative incidence of restored sinus rhythm
Time frame: During 48h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
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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.
Atar Shaul, MD principal investigator
Western Galilee Hospital
Nicola Makhoul, MD principal investigator
Western Galilee Hospital
Lilach Shema-didi, PhD principal investigator
Western Galilee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 3 inclusion and 7 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 25 Mar 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Lilach Shema-didi, PhD (972-507887538, lilach.shema-didi@naharia.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of phlebitis (time frame: during 24 h). 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 25 Mar 2013.