Study Comparing Pragmatic Use of Vernakalant and Amiodarone Treatments in the Emergency Room Management of Patients with Recent Onset Atrial Fibrillation.

Phase 1

• Conditions: Atrial Fibrilation; MedDRA version: 15.0Level: LLTClassification code 10007545Term: Cardiac dysrhythmiasSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000972-40-BE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-31
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 870

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

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 <100 mmHg.
4. Heart failure class NYHA III and NYHA IV, or previously documented LVEF = 35%.
5. Prolonged QT (uncorrected > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified