Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)
Brief Summary: To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).

To assess that dronedarone is well tolerated in this population.


Options:
A: Inclusion Criteria:

* a patient with persistent atrial fibrillation who received successful DC cardioversion

Exclusion Criteria:

* prior amiodarone use
* NYHA class III or IV heart failure
* Left ventricular ejection fraction \< 35%
* second or third AV block
* sick sinus syndrome
* heart rate \< 50 beat per minute
* myocardiac infarction within 3 months
* pregnant women
* severe hepatic dysfunction
* QT prolongation \> 500ms or PR interval \> 180ms
* history of hypersensitivity for drug
B: Inclusion Criteria:

* Comprehend and sign a written informed consent form, (per local and national regulations, as applicable)
* Be 18 to 85 years of age
* Women must not be pregnant, be non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 3 months after the last dose of medication. Methods of birth control considered to be effective may include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilisation. Men should be advised not to conceive a child and are advised to use an effective form of birth control from admission until 3 months after the last dose of study medication
* Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration and is clinically indicated for cardioversion;
* Have adequate anticoagulant therapy for cardioversion in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al, 2006);
* Be haemodynamically stable (100 mmHg \< systolic blood pressure \< 190 mmHg) at screening and on Day 1 before dosing (while taking rate control drugs, if required). After resting supine for 3 minutes, blood pressures should be measured 3 times in 5 minutes with at least 1 minute between assessments;
* Have a body weight between 45 and 113 kg (99 and 250 lbs).

Exclusion Criteria:

* Have known prolonged QT syndrome or QTcB interval of \>0.500 sec as measured at screening on a 12 lead ECG; familial long QT syndrome; previous Torsades de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT).
* Have a QRS \>0.140 sec;
* Documented previous episodes of second or third-degree atrioventricular block;
* Have clinically significant persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker;
* Have clinically significant moderate or severe aortic valvular stenosis (gradient \>25 mmHg), hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
* Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalized for heart failure in the previous 6 months;
* Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; h) Have serious pulmonary, hepatic, metabolic, renal (serum creatinine \> 2.0 mg/dl), gastrointestinal, central nervous system (CNS) or psychiatric disease, end-stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety;
* Have known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation \< 90% on room air), acute pericarditis, or myocarditis;
* Potassium (K+) \<3.5 mmol/L or \>5.5 mmol/L or magnesium (Mg2+) below the lower limit of normal (Mg2+\< 0.65 mmol/L in subjects 65 years or younger and \<0.80 mmol/L in subjects 66 years or older). (Both K+ and Mg2+ should be corrected prior to dosing);
* Have clinical evidence of digoxin toxicity;
* Have received an oral Class I or Class III antiarrhythmic agent (including sotalol) within 3 days of randomisation or oral amiodarone within 4 weeks, or have received intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24 hours prior to start of dosing;
* Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons;
* Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to screening;
* Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;
C: Inclusion Criteria:

* 1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline:

  * Hypertension (taking antihypertensive drugs of at least two different classes)
  * Diabetes
  * Prior cerebrovascular accident (stroke or transient ischemic attack) or systemic embolism
  * Left atrium diameter greater than or equal to 50 mm by echocardiography
  * Left ventricular ejection fraction less than 0.40 by 2D-echocardiography (two-dimensional echocardiography)
* 2. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL
* 3. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm

Exclusion Criteria:

General criteria:

* 1. Refusal or inability to give informed consent to participate in the study
* 2. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
* 3. Pregnant women (pregnancy test must be negative) or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception \[oral contraception or intra-uterine device (IUD)\] or sterile can be randomized.
* 4. Breastfeeding women
* 5. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
* 6. Previous participation in this trial

Criteria Related to a cardiac condition:

* 7. Patients in permanent atrial fibrillation
* 8. Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intra-venous pressor agents; patients on respirator; congestive heart failure of stage NYHA IV (New York Heart Association classification) within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization
* 9. Planned major non-cardiac or cardiac surgery or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG) , percutaneous coronary intervention (PCI) , or on urgent cardiac transplantation list
* 10. Acute myocarditis or constrictive pericarditis
* 11. Bradycardia \< 50 bpm and/or PR-interval \> 0.28 sec on the last 12-lead ECG
* 12. Significant sinus node disease (documented pause of 3 seconds or more) or 2nd or 3rd degree atrioventricular block (AV-block) unless treated with a pacemaker

Criteria Related to Concomitant Medications:

* 13. Need of a concomitant medication that is prohibited in this trial, including the requirement for Vaughan Williams Class I and III anti-arrhythmic drugs, that would preclude the use of study drug during the planned study period

Criteria Related to Laboratory Abnormalities:

* 14. Plasma potassium \< 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization)
* 15. A calculated Glomerular Filtration Rate (GFR) at baseline \<10 ml/min using the Cockroft Gault formula
D: Inclusion Criteria:

* Patients hospitalized with symptomatic CHF, current New York Heart Association (NYHA) class II-IV requiring treatment with a diuretic, who had had within the last month at least 1 episode of dyspnea or fatigue at rest, or on slight exertion corresponding to NYHA class III or IV
* Wall motion index (WMI) ≤1.2 determined by a blinded central evaluation of a recorded standard echocardiography, equivalent to a left ventricular ejection fraction (LVEF) ≤35%.

Exclusion Criteria:

* acute pulmonary edema within 12 hours prior to start of study medication
* various heart conditions (cardiogenic shock, obstructive valvular disease, obstructive cardiomyopathy; acute myocardial infarction, cardiac surgery, acute myocarditis or constrictive pericarditis, history of torsades de pointes, bradycardia \<50 bpm and/or PR-interval ≥280 ms, QTc-interval \>500 ms, significant sinus node disease)
* any illness or disorder other than CHF (cancer with metastasis, organ transplantation)
* current participation in another clinical study or currently taking an investigational drug including dronedarone or concomitant prohibited medication or treatment with other class I or III anti-arrhythmic drugs
* pregnant and/or breastfeeding women or women of child-bearing potential without adequate birth control
* serum potassium \<3.5 mmol/L.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Answer: C