Phase 2 N=241 Randomized Quadruple-blind Treatment

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

Persistent Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT01534962 ↗

Enrolled (actual)

241

Serious AEs

5.0%

Results posted

Aug 2014

Primary outcome: Primary: Time From Randomization to First Documented AF Recurrence. — 51.0; NA; 117.0; 58.0 Days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ranolazine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Menarini Group
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Time From Randomization to First Documented AF Recurrence.	51.0; NA; 117.0; 58.0	—
SECONDARY Number of Patients With Documented AF Recurrences	37; 25; 23; 31	—
SECONDARY Time From Randomization to First Documented and Confirmed AF Recurrence	73.0; NA; NA; NA	—
SECONDARY Number of Patients With Documented and Confirmed AF Recurrences	31; 19; 16; 24	—
SECONDARY Time From Randomization to First Documented AF Recurrence in Patients With Sinus Rhythm 48 Hours After Cardioversion	56.0; NA; 117.0; 78.0	—
SECONDARY Number of Patients in Sinus Rhythm 48 Hours After Cardioversion With Documented AF Recurrence	32; 19; 21; 27	—

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 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.

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Data sourced from ClinicalTrials.gov (NCT01534962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.