Clinical trial NCT01349491: Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion
Official title: Ranolazine for the Prevention of Recurrent Persistent Atrial Fibrillation After Electrical Cardioversion: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Ranolazine
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2011-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.

Detailed description: Atrial fibrillation (AF) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. Although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. However, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. Nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias.

Ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. Additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. However, there is no controlled data for the use of ranolazine to prevent recurrence of AF after electrical cardioversion of persistent AF.

The investigators hypothesize that ranolazine would decrease the incidence of recurrence of AF after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion. They will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of AF.

Eligibility criteria: Inclusion Criteria:

* Male or female with persistent atrial fibrillation, aged 21 or older
* Duration of atrial fibrillation less than one year
* The patient does not have any contraindications for anticoagulation
* The patient is willing to participate in the study for a total of 6 months with 3 outpatient office visits
* The patient has provided written informed consent during the screening visit to any test or procedure being performed, or medication being changed, for this study.
* The patient has no clinically significant abnormal clinical laboratory values, which in the investigator's opinion precludes the patient from safely participating in the study.

Exclusion Criteria:

* Any contraindication for anticoagulation
* New York Heart Association class IV heart failure
* Currently taking anti-arrhythmic drugs
* Chronic kidney disease (serum creatinine less than 2.5mg/dL) or severe liver dysfunction
* Pregnancy/nursing
* Prolonged QT interval (\>500ms)
* Taking other medications known to prolong the QT interval
* Taking other medications known to affect the metabolism of ranolazine

Primary outcomes:
measure: Primary Outcome - Number of Participants With Atrial Fibrillation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City VA Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Udho Thadani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Stavros Stavrakis, MD
role: STUDY_DIRECTOR
References: