Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, RSD1235, Atrial fibrillation of 3 hours to 7 days duration., Atrial fibrillation of 3 hours to 45 days duration.
Brief summary
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Detailed description
There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease & Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure. This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's abilities to convert AF to sinus rhythm. The patient population will include recent onset AF (AF duration of 3 hours to 7 days) and patients with longer AF duration. This is a double-blind, placebo-controlled, randomized study in patients with AF; stratification will be based on duration of AF. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.
Interventions
Sponsors
Astellas Pharma US, Inc.
Advanz Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older; * Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days. * Have adequate anticoagulant therapy.
Exclusion criteria
* Have a QRS \> 0.14 seconds unless patient has pacemaker or uncorrected QT \> 0.440 seconds as measured on a 12-lead ECG. * Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety. * Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm. | The proportion of patients with atrial fibrillation (AF) of 3 hours to 7 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment. |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of RSD1235 in this patient population. | The proportion of patients with AF of 3 hours to 45 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment. |
Countries
Canada, Denmark, Sweden, United States
Outcome results
None listed