Clinical trial NCT00125320: Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
Official title: A Phase III Study of the Conversion Efficacy and Safety of Repeated Intravenous Doses of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter Following Valvular and/or Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Treatment
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
name: Advanz Pharma
First posted: 2005-08-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.

Detailed description: This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.

Eligibility criteria: Inclusion Criteria:

* Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery

Exclusion Criteria:

* Unstable Class IV heart failure

Primary outcomes:
measure: Effectiveness of RSD1235
timeFrame: 90 minutes post infusion
Secondary outcomes:
measure: Proportion of patients in sinus rhythm at 90 minutes
timeFrame: Time from first exposure to conversion to sinus rhythm
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Buenos Aires
country: Argentina
city: La Plata
country: Argentina
city: Calgary
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Aalborg
country: Denmark
state: DK
city: Hellerup
country: Denmark
state: DK
city: Odense C
country: Denmark
state: DK
city: Bangalore
country: India
city: Chennai
country: India
city: Hyderabaad
country: India
city: Kerala
country: India
city: Mohali
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Warsaw
country: Poland
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204.