RAFFAELLO - Ranolazine in AF following an electrical cardioversion

• Research type

  Research Study

• Full title

  A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING PHASE II STUDY ASSESSING RANOLAZINE IN THE MAINTENANCE OF SINUS RHYTHM AFTER ELECTRICAL CARDIOVERSION IN PATIENTS WITH NON-PERMANENT ATRIAL FIBRILLATION

• IRAS ID

  94455

• Contact name

  A John Camm

• Sponsor organisation

  Menarini Ricerche S.p.A

• Eudract number

  2011-002789-18

• Research summary

  This clinical study aims at examining the potential benefit of the drug Ranolazine in the treatment of Atrial Fibrillation (AF) which is a cardiac arrhythmia (abnormal heart rhythm) that leads to an irregular heart beat and also to a reduced cardiac pump function. The anti-arrhythmic drugs currently available to prevent AF recurrence are of limited efficacy and many of them are associated with considerable side effects. For this reason, there is a high medical need for new agents which are potentially more effective and better tolerated than existing drugs. Eligible patients will be identified by the Investigator from those with non permanent AF which requires to be treated by electrical cardioversion. This study is expected to include approximately 240 patients (male, female) in approximately 40 cardiovascular centres across Europe (Germany, Italy, Spain and the United Kingdom). The study is divided into 3 study periods: 1)Screening lasting up to 7 days, 2)Treatment lasting up to 16 weeks, 3)Final Safety Follow-up performed at 2 weeks after end of treatment. A total of 5 site visits ( 1 follow-up telephone call) are planned for this study, during which the patient have to undergo the examination briefly described below: - Medical history, to record any previous/concomitant diseases and medication which may impact on the participation to the study. - Physical examination, including measurement of blood pressure and pulse rate, to evaluate patient's health status. - Complete electrocardiogram to evaluate the rhythm of heart and all other parameters. - An echocardiogram (i.e. an ultrasound examination of the heart via the chest) can also be requested, if not performed in the previous 6 months, to complete the evaluation of heart function. - Blood sampling and urinalysis to evaluate the status of blood, renal and hepatic function and metabolism. Pregnancy test (if applicable) will be also performed.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/0009

• Date of REC Opinion

  9 Feb 2012

• REC opinion

  Further Information Favourable Opinion