Atrial FibrillationPhase 3GILEADNCT01349491
Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion
A Phase 3 study testing Ranolazine in people with Atrial Fibrillation, run by University of Oklahoma at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ranolazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Jun 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
OU Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Ranolazine for the Prevention of Recurrent Persistent Atrial Fibrillation After Electrical Cardioversion: A Pilot Study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Ranolazine, Matching placebo
- Keywords
- Atrial Fibrillation, Ranolazine
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
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.
Matching placeboDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: low recruitement rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Udho Thadani, MD, Principal investigator, University of OklahomaStavros Stavrakis, MD, Study director, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349491
- Sponsor's protocol ID
- 2399
- Acronym
- GILEAD
- Status last verified
- Mar 2017
- First submitted
- 25 Apr 2011
- Last updated
- 27 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranolazine for the Prevention of Recurrent Persistent Atrial Fibrillation After Electrical Cardioversion: A Pilot Study
- ClinicalTrials.gov ID
- NCT01349491
- Acronym / sponsor ID
- GILEAD / 2399
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Ranolazine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitement rates
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Posted 27 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Experimental | Drug: RanolazinePatients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated. |
| Placebo | Placebo comparator | Drug: Matching placeboPatients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: RanexaPatients 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. | Drug | Ranolazine |
| Matching placeboAlso: PlaceboPatients 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. | Drug | Placebo |
Primary outcome
Primary Outcome - Number of Participants With Atrial Fibrillation
Time frame: 6 months
To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udho Thadani, MD principal investigator
University of Oklahoma
Stavros Stavrakis, MD study director
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranolazine in people with Atrial Fibrillation, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome - Number of Participants With Atrial Fibrillation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.