Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
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
1 other identifier
interventional
190
6 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 atrial-fibrillation
Started Jun 2004
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 28, 2005
CompletedFirst Posted
Study publicly available on registry
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 24, 2007
December 1, 2007
2.7 years
July 28, 2005
December 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of RSD1235
90 minutes post infusion
Secondary Outcomes (1)
Proportion of patients in sinus rhythm at 90 minutes
Time from first exposure to conversion to sinus rhythm
Interventions
Eligibility Criteria
You may qualify if:
- Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery
You may not qualify if:
- Unstable Class IV heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
- Advanz Pharmacollaborator
Study Sites (22)
Unknown Facility
Fort Lauderdale, Florida, 33308, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
La Plata, Argentina
Unknown Facility
Calgary, Alberta, T2N 2T9, Canada
Unknown Facility
Toronto, Ontario, M5B 1W8, Canada
Unknown Facility
Montreal, Quebec, H2L 4M1, Canada
Unknown Facility
Montreal, Quebec, H2W 1T8, Canada
Unknown Facility
Aalborg, DK, 9000, Denmark
Unknown Facility
Hellerup, DK, 2900, Denmark
Unknown Facility
Odense C, DK, 5000, Denmark
Unknown Facility
Bangalore, 562 158, India
Unknown Facility
Chennai, 600 037, India
Unknown Facility
Hyderabaad, 500 001, India
Unknown Facility
Kerala, 682 026, India
Unknown Facility
Mohali, 160 062, India
Unknown Facility
Mumbai, 400 051, India
Unknown Facility
New Delhi, 110 025, India
Unknown Facility
Katowice, 40-635, Poland
Unknown Facility
Krakow, 31-202, Poland
Unknown Facility
Lodz, 91-425, Poland
Unknown Facility
Warsaw, Poland
Related Publications (1)
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.
PMID: 19948506DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 28, 2005
First Posted
August 1, 2005
Study Start
June 1, 2004
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
December 24, 2007
Record last verified: 2007-12