ACT I
Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
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Status:
This study has been completed.
Purpose:
To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Interventions:
Vernakalant hydrochloride
Vernakalant hydrochloride (RSD-1235) is a mixed ion channel blocker with selectivity for atrial ion channels that does not promote ventricular arrhythmia. An i.v. formulation is in development for acute conversion of patients with atrial fibrillation or atrial flutter, and an oral formulation is being developed for the maintenance of sinus rhythm in patients at risk of developing atrial fibrillation.
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Location(s):
United States, Canada, Denmark, Sweden
Year Started:
2003
Year Finished:
2004
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study.
Inclusion Criteria
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.
Patient Involvement:
Patients were randomized in a 2:1 ratio to receive vernakalant or placebo and were stratified by AF duration of 3 hours to 7 days (short duration) and 8 to 45 days (long duration). A first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes, followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if AF was not terminated.
Primary Outcome:
To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Secondary Outcome:
To assess the safety of RSD1235 in this patient population.
Results:
The primary end point was conversion of AF to sinus rhythm for at least 1 minute within 90 minutes of the start of drug infusion in the short-duration AF group. A total of 336 patients were randomized and received treatment (short duration, n=220; long duration, n=116). Of the 145 vernakalant patients, 75 (51.7%) in the short-duration AF group converted to sinus rhythm (median time, 11 minutes) compared with 3 of the 75 placebo patients (4.0%; P<0.001). Overall, in the short- and long-duration AF groups, 83 of the 221 vernakalant patients (37.6%) experienced termination of AF compared with 3 of the 115 placebo patients (2.6%; P<0.001). Transient dysgeusia and sneezing were the most common side effects in vernakalant-treated patients. Four vernakalant-related serious adverse events (hypotension [2 events], complete atrioventricular block, and cardiogenic shock) occurred in 3 patients. In conclusion, Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated.
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Source of Information:
ClinicalTrial.gov
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Web Links and Publications:
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This information last updated on: 9/28/2009
Reviewed on: 09/28/2009.
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