A PHASE II STUDY ASSESSING RANOLAZINE IN ATRIAL FIBRILLATION FOLLWING AN ELECTRICAL CARDIOVERSIO

• Conditions: ON-PERMANENT ATRIAL FIBRILLATION; MedDRA version: 14.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002789-18-DE
• Lead Sponsor: Menarini Ricerche S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-08
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Male or female patients 18 years and older;
2. Patients with persistent AF suitable for electrical direct current
cardioversion (DCC);
NOTE: According to the ESC classification, persistent AF is defined as a
continuous AF with a minimum duration of 7 days or requiring
termination by cardioversion. Prior to randomisation, successful
electrical cardioversion and maintenance of sinus rhythm at 2 hours
shall be documented;
3. A female of childbearing potential may be enrolled providing she:
- has a negative pregnancy test at baseline and
- is routinely using an effective method of birth control resulting in a low
failure rate (e.g.. hormonal contraception, intrauterine device, condoms
in combination with a spermicidal cream, total sexual abstinence orsterilisation) until end of study which corresponds to the follow-up
safety call, 2 weeks after end of treatment;
4. Able to give written informed consent before any study related
procedure;
5. Able to attend all the visits scheduled in the study and able to independently record transtelephonic electrocardiograms (TT-ECGs) after being instructed 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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

1. Patients with first diagnosed AF (namely first onset of AF irrespective
of duration of arrhythmia or presence and severity of AF related
symptoms) or patients with paroxysmal AF (namely self-terminating AF
usually within 48 hours although it may continue for up to 7 days);
2. Patients with long-standing persistent AF (for this protocol defined as
AF longer than 6 months) or permanent AF (i.e. AF accepted by the
patient and by the physician);
3. Patients having known concurrent temporary secondary causes of AF
such as alcohol intoxication, pulmonary embolism, hyperthyroidism,
pneumonia, hypoxemia, acute pericarditis or myocarditis;
4. Patients having undergone atrial catheter ablation for AF;
5. Patients carrying a pacemaker;
6. Patients with electrolytes imbalances that may cause cardiac
arrhythmias, e.g. potassium < 3.5 mmol/L or > 5.5 mmol/L;
7. Patients with severe renal impairment (creatinine clearance < 30
ml/min);
8. Patients with ALT or AST > 2.5x upper limits of normal at screening or
severe hepatic impairment of any kind;
9. Patients taking potent CYP3A4 inhibitors (e.g. Itraconazole,
Ketoconazole, Voriconazol, Posaconazol, HIV protease inhibitors,
Clarithromycin, Telithromycin, Nefazodone);
10. Patients taking CYP3A4 inducers (e.g. Rifampicin, Phenytoin,
Phenobarbital, Carbamazepine, St. John's Wort);
11. Patients taking class I or Class III antiarrhythmic agents within 3
days of planned randomisation. NOTE: intravenous flecainide or
propafenone are allowed up to 72 hours and 24 hours from the planned
randomisation, respectively;
12. Patients taking beta-blockers unless used on stable doses for at least
2 weeks prior to the planned randomisation NOTE: Single doses of Intravenous beta-blockers are allowed up to 10 hours from the planned randomisation;
13. Patients taking Dronedarone or oral Amiodarone within 2 weeks and
3 months of planned randomisation, respectively. NOTE: Intravenous
administration of Amiodarone is prohibited within 72 hours from planned
randomisation;
14. Patients with a history of ECG abnormalities that in the opinion of the
Investigator render the subject unsuitable for the trial, including history
of congenital or a family history of long QT syndrome and a QTc interval
=450 msec at Screening;
15. Patients with congestive heart failure NYHA grade III and IV;
16. Patients known to be hypersensitive to Ranolazine or to any of the
components of the formulation;
17. Pregnant or breast feeding women;
18. Patients with any serious intercurrent illness (including psychiatric
and neurological disorders) which, in the opinion of the Investigator, is
incompatible with the protocol;
19. Abuse of alcohol (hazardous consumption defined as >30 g ethanol/day in men and >20 g/day in women), analgesics, or psychotropic
drugs;
20. Patients concurrently participating in another study, or who have
received an investigational drug within 30 days prior to screening;
21. Patients unable to communicate well with the Investigator and to
comply with the requirements of the entire study.
22. Patients with known cytochrome CYP2D6 enzyme deficiency (poor metabolisers).
23. Patients taking Metformin at a total daily dose greater than 1000 mg.
24. Patients taking Simvastatin at a total daily dose greater than 20 mg daily.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified