Paroxysmal Atrial FibrillationPhase 4AnPAFNCT01527279
Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation
A Phase 4 study testing antazoline and 0.9% saline in people with Paroxysmal Atrial Fibrillation, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- antazoline and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2012to Mar 2015
- 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
- Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted in Institute of Cardiology, Warsaw, Poland
- Age above 18 and good general condition
- Potassium level over 3.5 mmol/l
- Stable cardio-pulmonary state on enrollment
- In case of unclear history of heart failure or suspicion of impaired left ventricle function echocardiography is indicated prior to enrollment
- A long-term antiarrhythmic drug therapy is allowed
Who cannot join
- Lack of written informed consent
- Antazoline allergy
- AF related to significant valvular disease
- Clinically significant heart failure or ejection fraction < 55%
- Diastolic blood pressure (BP) < 100mmHg
- History of significant bradyarrhythmia not treated with permanent pacemaker
Show all 14Show fewer
- QT prolongation over 440ms or QTc (Bazett's formula) over population norm
- Tachycardia > 160'
- Advanced liver or kidney failure
- Acute coronary syndrome, coronary artery by-pass graft, stroke or transient ischemic attack within 30 days before enrollment
- Preexcitation in ECG not treated by radiofrequency ablation of accessory pathway
- Signs and symptoms of ischemia related to AF
- An investigational drug used within 30 days before enrollment
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Cardiology, II Dept. of Coronary Heart Disease
Warsaw, 02-637
About this study
Official title: Clinical Efficacy of Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation - a Single Centre, Randomized, Double-blind, Placebo-controlled Study (the AnPAF Study)
The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm.
Read the detailed description
Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia especially on atrial fibrillation (AF) facilitating rapid conversion to sinus rhythm. Despite relative lack of published data antazoline is marketed in Poland and widely used in cardiology wards and emergency rooms due to its efficacy, safety and rapid onset of action within minutes of administration.
To show superiority of antazoline over placebo a sample size of 80 patients was calculated based on following assumptions: two-tailed test, a type I error of 0.01, a power of 90%, efficacy of placebo 5%, efficacy of antazoline 50% and 20% drop-out rate to fulfill the criteria of intention-to-treat analysis. Due to presumed lack of statistical power the secondary end points and safety endpoints will be considered exploratory.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- antazoline, 0.9% saline
- Keywords
- atrial fibrillation, paroxysmal, cardioversion, antazoline
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antazolineDrug
Also called Phenazolinum
Patients assigned to antazoline group will be administered antazoline in boluses of 50mg diluted to 10cm3 every 5 minutes up to cumulative dose of 250mg or conversion of AF to SN. Drug administration will also be stopped in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection.
0.9% salineDrug
Patients assigned to control group will be administered 0.9% saline in boluses of 10cm3 every 5 minutes up to cumulative volume of 50cm3, conversion of AF to SN or in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines. Receives: Drug: 0.9% saline |
| Antazoline | Experimental | Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines. Receives: Drug: antazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus
Measured: 1.5 hour
Secondary outcomes (14)
Time to conversion of AF to SN
in minutes since first injection
Measured: 1.5 hour
Return of AF during observation period
Measured: 1.5 hour
Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation
Measured: 1.5 hour
Arterial pressure < 90mmHg
Measured: 1.5 hour
Disturbances of atrio-ventricular conduction
Measured: 1.5 hour
Sustained supraventricular arrhythmia other than AF
Measured: 1.5 hour
New complex ventricular arrhythmia
Ventricular arrhythmia other than premature ventricular contraction
Measured: 1.5 hour
Hot flush
Measured: 1.5 hour
Drowsiness
Measured: 1.5 hour
Headache
Measured: 1.5 hour
Nausea/ vomiting
Measured: 1.5 hour
Chest pain
Measured: 1.5 hours
Tachycardia >180'
Measured: 1.5 hours
Prolongation of QTc in ms (Bazett's formula) in comparison to baseline
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna Szwed, MD, PhD, Study chair, National Institute of Cardiology, Warsaw, PolandAleksander Maciag, MD, PhD, Principal investigator, National Institute of Cardiology, Warsaw, PolandMichal M Farkowski, MD, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527279
- Sponsor's protocol ID
- Antazoline
- Acronym
- AnPAF
- Status last verified
- May 2015
- First submitted
- 2 Feb 2012
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farkowski MM, Maciag A, Dabrowski R, Pytkowski M, Kowalik I, Szwed H. Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation--a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study). Trials. 2012 Sep 11;13:162. doi: 10.1186/1745-6215-13-162.
PubMed 22967497Maciag A, Farkowski MM, Chwyczko T, Beckowski M, Syska P, Kowalik I, Pytkowski M, Wozniak J, Dabrowski R, Szwed H. Efficacy and safety of antazoline in the rapid cardioversion of paroxysmal atrial fibrillation (the AnPAF Study). Europace. 2017 Oct 1;19(10):1637-1642. doi: 10.1093/europace/euw384.
PubMed 28339554
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation - a Single Centre, Randomized, Double-blind, Placebo-controlled Study (the AnPAF Study)
- ClinicalTrials.gov ID
- NCT01527279
- Acronym / sponsor ID
- AnPAF / Antazoline
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- atrial fibrillation, paroxysmal, cardioversion, antazoline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Feb 2012 (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 randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm.
Detailed description
Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia especially on atrial fibrillation (AF) facilitating rapid conversion to sinus rhythm. Despite relative lack of published data antazoline is marketed in Poland and widely used in cardiology wards and emergency rooms due to its efficacy, safety and rapid onset of action within minutes of administration.
To show superiority of antazoline over placebo a sample size of 80 patients was calculated based on following assumptions: two-tailed test, a type I error of 0.01, a power of 90%, efficacy of placebo 5%, efficacy of antazoline 50% and 20% drop-out rate to fulfill the criteria of intention-to-treat analysis. Due to presumed lack of statistical power the secondary end points and safety endpoints will be considered exploratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9% salineAny patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines. |
| Antazoline | Experimental | Drug: antazolineAny patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted in Institute of Cardiology, Warsaw, Poland
- Age above 18 and good general condition
- Potassium level over 3.5 mmol/l
- Stable cardio-pulmonary state on enrollment
- In case of unclear history of heart failure or suspicion of impaired left ventricle function echocardiography is indicated prior to enrollment
Key exclusion criteria (14 listed)
- Lack of written informed consent
- Antazoline allergy
- AF related to significant valvular disease
- Clinically significant heart failure or ejection fraction < 55%
- Diastolic blood pressure (BP) < 100mmHg
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 |
|---|---|---|
| antazolineAlso: PhenazolinumPatients assigned to antazoline group will be administered antazoline in boluses of 50mg diluted to 10cm3 every 5 minutes up to cumulative dose of 250mg or conversion of AF to SN. Drug administration will also be stopped in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection. | Drug | Antazoline |
| 0.9% salinePatients assigned to control group will be administered 0.9% saline in boluses of 10cm3 every 5 minutes up to cumulative volume of 50cm3, conversion of AF to SN or in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection. | Drug | Placebo |
Primary outcome
Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus
Time frame: 1.5 hour
14 secondary outcomes
Time to conversion of AF to SN
Time frame: 1.5 hour
Return of AF during observation period
Time frame: 1.5 hour
Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation
Time frame: 1.5 hour
Arterial pressure < 90mmHg
Time frame: 1.5 hour
Disturbances of atrio-ventricular conduction
Time frame: 1.5 hour
Sustained supraventricular arrhythmia other than AF
Time frame: 1.5 hour
New complex ventricular arrhythmia
Time frame: 1.5 hour
Hot flush
Time frame: 1.5 hour
Drowsiness
Time frame: 1.5 hour
Headache
Time frame: 1.5 hour
Nausea/ vomiting
Time frame: 1.5 hour
Chest pain
Time frame: 1.5 hours
Tachycardia >180'
Time frame: 1.5 hours
Prolongation of QTc in ms (Bazett's formula) in comparison to baseline
Time frame: 1.5 hours
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 22 May 2015.
- Background: PubMed 22967497Farkowski MM, Maciag A, Dabrowski R, Pytkowski M, Kowalik I, Szwed H. Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation--a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study). Trials. 2012 Sep 11;13:162. doi: 10.1186/1745-6215-13-162.
- Derived from this study: PubMed 28339554Maciag A, Farkowski MM, Chwyczko T, Beckowski M, Syska P, Kowalik I, Pytkowski M, Wozniak J, Dabrowski R, Szwed H. Efficacy and safety of antazoline in the rapid cardioversion of paroxysmal atrial fibrillation (the AnPAF Study). Europace. 2017 Oct 1;19(10):1637-1642. doi: 10.1093/europace/euw384.
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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.
Hanna Szwed, MD, PhD study chair
National Institute of Cardiology, Warsaw, Poland
Aleksander Maciag, MD, PhD principal investigator
National Institute of Cardiology, Warsaw, Poland
Michal M Farkowski, MD principal investigator
National Institute of Cardiology, Warsaw, Poland
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 antazoline and 0.9% saline in people with Paroxysmal Atrial Fibrillation, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 6 inclusion and 14 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 22 May 2015. 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 Poland. 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?
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?
Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus (time frame: 1.5 hour). 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 NCT01527279, which also lists 2 linked publications.
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 22 May 2015.