Double blind placebo controlled dose ranging study of the efficacy and safety of SSR149744C 300 or 600 mg for the conversion of atrial fibrillation/flutter - CORYFEE
- Conditions
- Atrial fibrillation/flutterMedDRA version: 7.1Level: LLTClassification code 10003658
- Registration Number
- EUCTR2005-000823-40-PT
- Lead Sponsor
- Sanofi-Synthelabo-Recherche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 141
- AF/AFL for >72 hours and documented by 2 12-lead ECG recorded prior to randomization, separated by at least 72 hours and both showing AF/AFL
- Indication for cardioversion of the current AF/AFL episode as judged by the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Women of childbearing potential without adequat birthcontrol, pregnant women and breastfeeding women.
-Contraindication to oral anti-coagulant
Criteria related to a cardiac condition or a disease resistance :
-Permanent cardiac pacemaker or ICD
-Unstable angina pectoris or recent myocardial infarction
-Acute condition known to cause AF/AFL
-History of torsades de pointes
-Congenital long QT syndrome
-QT-interval > 500 msec on the last 12-lead ECG before randomization
-Family history of sudden cardiac death below age 50 years in the absence of coronary heart disease
-Wolff-Parkinson-White syndrome
-History of high degree atrio-ventricular block
-PR-interval ³ 0.28 sec
-Significant sinus node disease
-Bradycardia < 50 bpm on the last 12-lead ECG before randomization
-Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization,
-Left ventricular ejection fraction less than 35% on the screening 2D-echocardiogram
-Ongoing potentially dangerous symptoms when in AF/AFL such as angina pectoris, transient ischemic attacks, stroke, syncope as judged by the investigator
-Patients known to have permanent AF/AFL
-Patients in whom 3 (on different days) consecutive electrical cardioversions were unsuccessful in re-establishing sinus rhythm.
Other exclusion criteria : related to clinically relevant laboratory abnormalities and related to some concommitant medications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.;Secondary Objective: -To assess versus placebo the efficacy of SSR149744C for the control of ventricular rate in patients not converted at the time of the planned electrical cardioversion.<br>-To assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population.<br>-To document SSR149744C plasma levels during the study.<br>;Primary end point(s): Rate of conversion to sinus rhythm documented by ECG at the time of planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
- Secondary Outcome Measures
Name Time Method