NCT01349491

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 27, 2017

Completed
Last Updated

April 27, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

April 25, 2011

Results QC Date

January 10, 2017

Last Update Submit

March 16, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationRanolazine

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome - Number of Participants With Atrial Fibrillation

    To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.

    6 months

Study Arms (2)

Ranolazine

EXPERIMENTAL

Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.

Drug: Matching placebo

Interventions

RanolazineDRUG

Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.

Also known as: Ranexa
Ranolazine
Matching placeboDRUG

Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.

Also known as: Placebo
Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Stavros Stavrakis
Organization
University of Oklahoma Health Sciences Center
stavros-stavrakis@ouhsc.edu
405-271-9696

Study Officials

  • Udho Thadani, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

  • Stavros Stavrakis, MD

    University of Oklahoma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2011

First Posted

May 6, 2011

Study Start

March 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 27, 2017

Results First Posted

April 27, 2017

Record last verified: 2017-03

Locations

US(2)