Atrial Fibrillation New OnsetNCT01590979
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
A study testing Ranolazine in people with Atrial Fibrillation New Onset and Hemorrhage, run by Northwell Health at 1 site in United States.
Trial summary
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval
- What is being tested?
- Ranolazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - Aortic or Tricuspid or Pulmonary valves
- Patients who are not previously on Ranolazine
- Do not have a history of arrhythmia and are not on any antiarrhythmic therapy
- Patients with QTc on a 12 lead EKG of less than or equal to 460 ms
- Patients with estimated Glomerular Filtration Rate (GFR) greater than 30 mL/min/1.73 m2 on the initial lab work
- Available at least 48 hours before surgery
Who cannot join
- Patients who are not undergoing above surgeries
- Patients undergoing surgery for mitral valve replacement/repair
- Patient with cirrhosis
- Pregnant patients
- Patients with chronic atrial fibrillation
- Patients who had prior adverse drug reactions or allergies to Ranolazine
Show all 9Show fewer
- Patients who are already taking Ranolazine prior to the study
- Patient who are reported HIV Positive (as there are antiretroviral drug interactions)
- Patients who are on drugs listed in Appendix A prior to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hosptial
Staten Island, New York, 10305
About this study
Official title: Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
Read the detailed description
Atrial fibrillation (AF) is a common complication of cardiac surgery. It has been shown that the onset of AF increases in post-operative cardiac surgery population. The rate of AF after coronary artery bypass graft (CABG) procedure range from 10-65% and from 37-50% after valve surgery. Rates of new onset AF are lower for CABG compared to valve procedures. The pathophysiology of post-operative AF is not well elucidated. It has been postulated that pre-operative factors such as age, past medical history, operative and post-operative remodeling of the coronary system and hemodynamic pressure changes may contribute to post-operative AF.
Ranolazine is currently approved as an antianginal drug. The antianginal properties of the drug are due to inhibition of the late inward sodium current. Through the same mechanism it has been demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Therefore it is important to prevent or minimize the incidence of new onset post-operative AF in post-surgical population.
- Conditions
- Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval, Ventricular Tachycardia, Medical Care; Complications, Late Effect of Complications
- Being tested
- Ranolazine, Placebo
- Keywords
- Atrial Fibrillation New Onset, Ranolazine, CABG, valve repair/replacement, Cardiac Surgery
- Medical subject headings
- Hemorrhage, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called RANEXA®
1000mg, two times a day, 12 hour intervals
PlaceboDrug
Also called Sugar pill
two times a day, 12 hour intervals
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Active comparator | The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Receives: Drug: Ranolazine |
| Placebo | Placebo comparator | Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients
Measured: 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: The study was terminated due to slow rate of accrual resulting in a sample size.
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 Fibrillation New OnsetStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Soad Bekheit, Northwell Health
- Investigators
- Soad Bekheit, MD, Principal investigator, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590979
- Sponsor's protocol ID
- Bekheit-Ranolazine
- Status last verified
- Feb 2017
- First submitted
- 27 Apr 2012
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT01590979
- Acronym / sponsor ID
- Bekheit-Ranolazine
- Conditions
- Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval, Ventricular Tachycardia, Medical Care; Complications, Late Effect of Complications
- Keywords
- Atrial Fibrillation New Onset, Ranolazine, CABG, valve repair/replacement, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to slow rate of accrual resulting in a sample size.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
Detailed description
Atrial fibrillation (AF) is a common complication of cardiac surgery. It has been shown that the onset of AF increases in post-operative cardiac surgery population. The rate of AF after coronary artery bypass graft (CABG) procedure range from 10-65% and from 37-50% after valve surgery. Rates of new onset AF are lower for CABG compared to valve procedures. The pathophysiology of post-operative AF is not well elucidated. It has been postulated that pre-operative factors such as age, past medical history, operative and post-operative remodeling of the coronary system and hemodynamic pressure changes may contribute to post-operative AF.
Ranolazine is currently approved as an antianginal drug. The antianginal properties of the drug are due to inhibition of the late inward sodium current. Through the same mechanism it has been demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Therefore it is important to prevent or minimize the incidence of new onset post-operative AF in post-surgical population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Active comparator | Drug: RanolazineThe antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. |
| Placebo | Placebo comparator | Drug: PlaceboCompany generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - Aortic or Tricuspid or Pulmonary valves
- Patients who are not previously on Ranolazine
- Do not have a history of arrhythmia and are not on any antiarrhythmic therapy
- Patients with QTc on a 12 lead EKG of less than or equal to 460 ms
- Patients with estimated Glomerular Filtration Rate (GFR) greater than 30 mL/min/1.73 m2 on the initial lab work
Key exclusion criteria (9 listed)
- Patients who are not undergoing above surgeries
- Patients undergoing surgery for mitral valve replacement/repair
- Patient with cirrhosis
- Pregnant patients
- Patients with chronic atrial fibrillation
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: RANEXA®1000mg, two times a day, 12 hour intervals | Drug | Ranolazine |
| PlaceboAlso: Sugar pilltwo times a day, 12 hour intervals | Drug | Placebo |
Primary outcome
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients
Time frame: 3 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The conversion of paroxysmal or initial onset atrial fibrillation with oral Ranolazine: Implications for a new "pill-in-pocket" approach in structural heart disease.Link provided by the sponsor.
- Comparison of effectiveness and safety of Ranolazine versus amiodarone for preventing atrial fibrillation after coronary artery bypass grafting.Link provided by the sponsor.
- Electrophysiologic basis for the antiarrhythmic actions of Ranolazine. Heart Rhythm.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Soad Bekheit, MD principal investigator
Staten Island University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranolazine in people with Atrial Fibrillation New Onset and Hemorrhage, run by Northwell Health at 1 site 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 9 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 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?
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients (time frame: 3 weeks after surgery). 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 23 Mar 2017.