A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)

• Status: Withdrawn
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiome Pharma; Correvio International Sarl
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

• Symptomatic AF (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization

• If 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.

• Weigh at least 45 kg

• Receiving adequate anticoagulant therapy

Exclusion Criteria:

• Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine

• Severe aortic stenosis

• Systolic blood pressure <100 mmHg

• New York Heart Association (NYHA) Class III or IV heart failure

• Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker

• Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration

• Acute coronary syndrome (including myocardial infarction) within previous 30 days

• History of thyroid dysfunction

• Severe acute respiratory failure or cardiovascular collapse

• Participating in another drug study or has received an investigational drug within 30 days prior to enrollment

• Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up