Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Ranolazine; Ranolazine; Ranolazine; Placebo
Intervention description: Oral administration, BID; for a maximum of 112 days.; Oral administration, BID; for a maximum of 112 days.; Oral administration, BID; for a maximum of 112 days.; Oral administration, BID; for a maximum of 112 days.
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Ranolazine; Arrhythmias, Cardiac; Antiarrhythmic Agents; Cardiac Electroversion; Ranexa

Summary:

      Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low,
      intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful
      electrical cardioversion in patients with persistent atrial fibrillation (AFib).

      After successful cardioversion and subsequent randomisation, patients report trans-telephonic
      EGCs on a daily basis to a central core ECG facility.

      Maximum treatment duration is 112 days (16 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients 18 years and older

          -  Patients with persistent AF suitable for electrical direct current cardioversion (DCC)

          -  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 until end of study

          -  Able to give written informed consent before any study related procedure

          -  Able to attend all the visits scheduled in the study

        Exclusion Criteria:

          -  Patients with first diagnosed AF or patients with paroxysmal AF

          -  Patients with long-standing persistent AF or permanent AF

          -  Patients having known concurrent temporary secondary causes of AF such as alcohol
             intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia, acute
             pericarditis or myocarditis

          -  Patients having undergone atrial catheter ablation for AF

          -  Patients carrying a pacemaker

          -  Patients with electrolytes imbalances that may cause cardiac arrhythmias, e.g.
             potassium < 3.5 mmol/L or > 5.5 mmol/L

          -  Patients with any contra-indications to Ranexa according to the drug-specific product
             characteristics

          -  Patients taking class I or Class III antiarrhythmic agents within 3 days of planned
             randomisation

          -  Patients taking beta-blockers unless used on stable doses for at least 2 weeks prior
             to the planned randomisation. Single doses of Intravenous beta-blockers are allowed up
             to 10 hours from the planned randomisation

          -  Patients taking Dronedarone or oral Amiodarone within 2 weeks and 3 months of planned
             randomisation, respectively

          -  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 ≥500 msec at Screening

          -  Patients with congestive heart failure NYHA grade III and IV;

          -  Patients with any serious intercurrent illness (including psychiatric and neurological
             disorders) which, in the opinion of the Investigator, is incompatible with the
             protocol.

          -  Patients taking Metformin at a total daily dose greater than 1000 mg.

          -  Patients taking Simvastatin at a total daily dose greater than 20 mg.