CLINICAL TRIAL

Dronedarone for Atrial Fibrillation

Locally Advanced
Newly Diagnosed
Recurrent
Recruiting · 18+ · All Sexes · Camden, NJ

Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation

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About the trial for Atrial Fibrillation

Treatment Groups

This trial involves 2 different treatments. Dronedarone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Dronedarone
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronedarone
FDA approved

Side Effect Profile for Ranolazine 750 mg + Dronedarone 150 mg

Ranolazine 750 mg + Dronedarone 150 mg
Show all side effects
15%
Constipation
8%
Atrial fibrillation
8%
Gastrooesophageal reflux disease
8%
Gastritis
8%
International normalised ratio increased
8%
Dizziness
8%
Asthenia
8%
Cough
4%
Vertigo
4%
Diarrhoea
4%
Fatigue
4%
Dyspnoea
4%
Hypertension
4%
Hypotension
4%
Nausea
0%
Pruritus
0%
Cardiac failure congestive
0%
Presyncope
0%
Abdominal distension
0%
Urinary tract infection
0%
Abdominal pain
0%
Prothrombin time prolonged
0%
Back pain
0%
Nasopharyngitis
0%
Gastrointestinal haemorrhage
0%
Chest pain
0%
Atrial flutter
0%
Tachyarrhythmia
0%
Clostridium difficile colitis
0%
Enterococcal bacteraemia
0%
Cerebrovascular accident
0%
Syncope
0%
Oedema peripheral
0%
Overdose
0%
Haematoma
Constipation
15%
Atrial fibrillation
8%
Gastrooesophageal reflux disease
8%
Gastritis
8%
International normalised ratio increased
8%
Dizziness
8%
Asthenia
8%
Cough
8%
Vertigo
4%
Diarrhoea
4%
Fatigue
4%
Dyspnoea
4%
Hypertension
4%
Hypotension
4%
Nausea
4%
Pruritus
0%
Cardiac failure congestive
0%
Presyncope
0%
Abdominal distension
0%
Urinary tract infection
0%
Abdominal pain
0%
Prothrombin time prolonged
0%
Back pain
0%
Nasopharyngitis
0%
Gastrointestinal haemorrhage
0%
Chest pain
0%
Atrial flutter
0%
Tachyarrhythmia
0%
Clostridium difficile colitis
0%
Enterococcal bacteraemia
0%
Cerebrovascular accident
0%
Syncope
0%
Oedema peripheral
0%
Overdose
0%
Haematoma
0%
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01522651) in the Ranolazine 750 mg + Dronedarone 150 mg ARM group. Side effects include: Constipation with 15%, Atrial fibrillation with 8%, Gastrooesophageal reflux disease with 8%, Gastritis with 8%, International normalised ratio increased with 8%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Atrial Fibrillation. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age >=60 years
First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 60 days)
Electrocardiographic documentation of atrial fibrillation.
Estimated life expectancy of at least 1 year
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At baseline and 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: At baseline and 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At baseline and 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dronedarone will improve 1 primary outcome, 7 secondary outcomes, and 7 other outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of Evaluated through 12 months from randomization.

Unplanned cardiovascular hospitalizations--secondary analysis using Anderson-Gill extension
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The second exploratory analysis of unplanned cardiovascular hospitalization will use a method to account for repeated events (Anderson-Gill extension).
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Win Ratio
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Among the randomized patients, every patient in the dronedarone arm will be compared with every patient in the usual care arm. Within each pair of patients, the component outcomes will be compared in descending order of importance until one of the patients in the pair demonstrates a better outcome compared with the other. For the purpose of this trial the hierarchy of component outcomes are shown below. The components in the WIN ratio hierarchy are similar to the endpoints considered in the recent EAST AFNET4 trial. Hierarchy of Outcomes for the WIN Ratio: All-cause mortality Ischemic stroke or systemic embolism Hospitalization for new/worsening diagnosis of heart failure Hospitalization for acute coronary syndrome
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Hospitalization for acute coronary syndrome
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Any hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to acute coronary syndrome.
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Cardiovascular Hospitalization or Death
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
First occurrence of unplanned CV hospitalization or death from any cause within 12 months of randomization. All unplanned hospitalizations (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) for cardiovascular causes will be considered a cardiovascular hospitalization.
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Time to first unplanned cardiovascular hospitalization
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The key secondary endpoint will be time to first unplanned CV hospitalization (similar to the component of the primary endpoint).
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Number of participants who undergo cardioversion (pharmacologic or electrical)
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
Cardioversion (either pharmacologic or electrical) with or without transesophageal echocardiographic guidance will be a tertiary endpoint.
EVALUATED THROUGH 12 MONTHS FROM RANDOMIZATION
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of atrial fibrillation?

The findings of this study may serve as a guide in the clinical evaluation of patients with AF and may help to guide the clinician in the choice of anti-arrhythmic therapy.

Anonymous Patient Answer

What is atrial fibrillation?

AF is a type of heart rhythm disorder characterized by rapid heart rates and irregular fibrillations. As a consequence of these irregular beats, the blood pressure in the body begins to fall abruptly, leading to increased chances of heart attack or stroke. The disorder is also correlated with increased odds of atrial fibrillation after an acute myocardial infarction. It is the largest cause of sudden death in people under 60 years of age. As of 2018, approximately 1.5 million people in the United States are diagnosed with the condition and approximately 300,000 to 400,000 people in the United States will die from it per year.

Anonymous Patient Answer

What are common treatments for atrial fibrillation?

There are many different ways to treat atrial fibrillation. While the best way to treat atrial fibrillation is for every unique person affected by the condition to choose that specific way, there are some ways that any doctor will go about treating atrial fibrillation. One very popular way to prevent atrial fibrillation is by getting vaccinated daily, using medicines such as warfarin and ACE inhibitors to help prevent the development of atrial fibrillation, and quitting the habit of smoking. There are also some different methods of treatment that are in use in the United States, including the use of cardioversion and atrial ablation.

Anonymous Patient Answer

Can atrial fibrillation be cured?

Although an important proportion of subjects with AF can be treated to achieve long-term PVI benefit, the use of this emerging AF treatment strategy is hampered by the persistence of AF in the majority of subjects.

Anonymous Patient Answer

What causes atrial fibrillation?

Atrial fibrillation has been linked with the presence of an underlying abnormality, usually valvular or cardiac or even to an underlying mental problem. It also has been argued that there may be some genetic predisposition which can be traced back to the fetal development period of the early human embryonic development. There is some evidence supporting the idea that many of our psychological problems can have an impact on the development of the atria. Atrial fibrillation is thought to be a disease process of the atrylia, or parts of the atria, such as the valves of the heart or sino-atrial node, the muscular parts of the atria, or the surrounding connective tissues.

Anonymous Patient Answer

How many people get atrial fibrillation a year in the United States?

The incidence of AF in U.S. population is very high and it is expected to increase in a decade at our current rate of change.

Anonymous Patient Answer

Does atrial fibrillation run in families?

In a recent study, findings of the above analyses suggest that the occurrence of atrial fibrillation in the analyzed patients is not connected with hereditary predisposition to the arrhythmia. As a matter of fact familial aggregation seems to be rather weak.

Anonymous Patient Answer

What is dronedarone?

The anti-arrhythmic drug is effective in terminating the arrhythmia (ATPR≥2 in both groups). The higher prevalence of symptomatic re-arrhythmia (ATPR≤1.3) in group D (ATPR=2) might favor use of another anti-arrhythmic drug (for example, amiodarone) when an anti-arrhythmic drug is not working properly.

Anonymous Patient Answer

Has dronedarone proven to be more effective than a placebo?

This randomized, double-blind study demonstrated that for an average of 4 years, one-half-million-dose dronedarone is markedly more effective versus placebo in the prevention of atrial fibrillation.

Anonymous Patient Answer

What does dronedarone usually treat?

The side effects usually outweigh the symptomatic benefit of dronedarone. The most common side effect of dronedarone is sinus arrhythmia. When dronedarone is taken with another medication the side effects tend to be lessened to the extent that they usually do not constitute a significant issue. The use of dronedarone with concomitant use of the antimuscarinic medication diphenhydramine may lead to severe and potentially fatal allergic reactions that can occur either during the administration of both or anytime afterwards. The most severe of which result in pulmonary symptoms requiring intubation, hemodynamic instability, and even death. This is a rare but very serious and potentially life-threatening adverse effect.

Anonymous Patient Answer

What are the latest developments in dronedarone for therapeutic use?

Dronedarone has a number of unique pharmacologic properties that have proven it to be a viable therapeutic agent for the treatment of patients with refractory AF. It achieves therapeutic levels and is well tolerated in patients. This may prove beneficial during the first few weeks of therapy while we assess the safety profile of dronedarone.

Anonymous Patient Answer

Is dronedarone safe for people?

Dronedarone is relatively safe. Although it may cause an isolated event of nausea or vomiting for some patients, the overall risk is low and is outweighed by the benefit of improved arrhythmia outcomes.

Anonymous Patient Answer
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