Atrial Fibrilation MedDRA version: 15.0 Level: LLT Classification code 10007545 Term: Cardiac dysrhythmias System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: BRINAVESS 20 mg/ml, concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vernakalant Hydrochloride
CAS Number: 748810-28-8
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptomatic AF (duration of current episode is =7 days), is hemodynamically stable, and has no other condition at the time of screening that may result in acute hospitalization. The treating physician has determined that the patient is eligible for acute cardioversion and no additional diagnostic evaluation is required that may delay cardioversion. 2. Non-surgery adult patient with AF, duration of current episode = 7 days 3. Documented AF by ECG. 4. Understanding of the study procedures and has given informed consent. 5. If the patient is female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up. Acceptable methods of birth control are: intrauterine device,diaphragm with spermicide, contraceptive sponge, condom, partner vasectomy, hormonal contraception. 6. Weighing at least 45 kg. 7. Receiving adequate anticoagulant therapy as defined by the clinical practice of the Investigator. If the investigator believes that the patient does not need anticoagulant therapy, it is acceptable. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 440 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 430
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine. 2. Severe aortic stenosis. 3. Systolic blood pressure 440 msec) on screening ECG. 6. Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker. 7. Use of intravenous rhythm control anti-arrhythmics (class I and III) within 4 hours of study drug administration. 8. Acute coronary syndrome (including myocardial infarction) within the last 30 days. 9. Evidence of history of thyroid dysfunction, as determined by the investigator. 10. Severe acute respiratory failure or cardiovascular collapse. 11. Currently using any medications known to prolong the QT interval, including but not limited to: erythromycin, co-timoxazole, pentadine injection, chlorpromazine, thioridazine, pimozide, haloperidol, lithium, tri-cyclic antidepressants (e.g. doxepin, maprotiline, and amitriptyline, terfenadine, astmemizole, and anti-malarial agents (e.g. quinine, mefloquine, chloroquine, and halofantrine). 12. Currently participating in another drug study or has received an investigational drug within 30 days prior to enrollment. 13. Pregnant (positive serum ß-HCG) or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up. 14. Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study. 15. Any occurrence of atrial flutter (AFL) at screening. 16. Complex ventricular ectopy (i.e., idioventricular rhythm, accelerated idioventricular rhythm, sustained or unsustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, ventricular flutter, or frequent polymorphic premature ventricular complexes) on any ECG or on heart monitoring during screening or at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the primary use of vernakalant results in a higher proportion of patients discharged from the ER to home, home-equivalent, or LTCF within 12 hours from randomization compared to the primary use of amiodarone in patients with recent onset AF (current episode =7 days) who present for rapid conversion.;Secondary Objective: Objective 1: To determine whether the primary use of vernakalant reduces the proportion of patients admitted to a hospital (acute care, intensive care, or any other unit with a higher level of care than the ER) from the ER compared to primary use of amiodarone for rapid conversion of recent onset AF (current episode =7 days) in the ER. Objective 2: To assess the safety of a primary vernakalant approach compared to a primary amiodarone approach for acute cardioversion in patients with recent onset AF (current episode =7 days).;Primary end point(s): The primary efficacy endpoint is the proportion of patients discharged from the ER to home, home-equivalent, or LTCF within 12 hours from randomization. Patients who withdraw after infusion of any amount of study medication prior to observing the endpoint will have a response of not discharged imputed for the primary endpoint.;Timepoint(s) of evaluation of this end point: Within 12 hours from randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoint is the overall hospitalization rate, which is calculated as the proportion of patients admitted to hospital directly from the ER after randomization.;Timepoint(s) of evaluation of this end point: After randomization during study period. | — |
Countries
Belgium, Brazil, France, Italy, Portugal
Contacts
Public ContactSarah Camp
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed