Heart; Dysfunction Postoperative, Cardiac SurgeryPhase 3NCT01352416

Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

A Phase 3 study testing Ranolazine in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Corewell Health East at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Heart; Dysfunction Postoperative, Cardiac Surgery
What is being tested?: Ranolazine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 2 sitesUnited States
Study dates: Sep 2010to Nov 2012
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.

Who cannot join

Documented atrial fibrillation within the previous 3 months
Ongoing therapy with suppressive antiarrhythmic drugs
Patient currently on digoxin
Emergent surgery
Patient receiving hemodialysis
Concomitant use of ketoconazole, diltiazem, verapamil

Show all 9Show fewer

Known tolerance or hypersensitivity to ranolazine
Pregnant individuals
MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery

Trial locations and contacts

2 sites in 1 country.

United States2 sites

William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospital
Troy, Michigan, 48085-1198

Other trials in United States

About this study

The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery

Read the detailed description

A single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (Coronary Artery Bypass Graft [CABG], or valve or CABG and valve). All patients who meet criteria will be prospectively enrolled in a randomized fashion. Patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. Study drug will be initiated 2 days before surgery. Patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. Patients will be seen in 2 weeks and receive a 30 day follow up contact visit.

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Being tested: Ranolazine, Placebo
Keywords: Suppress Atrial Fibrillation, heart bypass surgery, heart valve surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RanolazineDrug
Also called Ranexa
Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily
PlaceboDrug
Also called inactive ingredients pill
Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily

Study groups in NCT01352416
Study group	Role	What they receive
CABG surgery with Ranolazine	Active comparator	Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Ranolazine 1000 mg (2-500mg tablets) twice daily. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg (1-500mg tablet) twice daily. Receives: Drug: Ranolazine
CABG surgery with placebo	Placebo comparator	Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Placebo 1000mg mg (2-500mg tablets)twice daily. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily. Receives: Drug: Placebo
Heart Valve surgery with Ranolazine	Active comparator	Patient will undergo heart Valve surgery and will receive, Ranolazine1000mg (2-500 mg tablets) twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg (1-500mg tablet) twice a day. Receives: Drug: Ranolazine
Heart Valve surgery with placebo	Placebo comparator	Patient will undergo heart Valve surgery and will receive, Placebo 1000mg (2-500mg tablets) twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice a day. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.
Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.
Measured: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Nov 2012

First posted11 May 2011 (estimated)
Study startSep 2010
Primary completionNov 2012
Study completionNov 2012

Why it stopped: lack of enrollment

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 Heart; Dysfunction Postoperative, Cardiac SurgeryStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01352416
Sponsor's protocol ID: 2009-101, IN-US-259-0114
Status last verified: Nov 2016
First submitted: 4 May 2011
Last updated: 6 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart; Dysfunction Postoperative, Cardiac Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
ClinicalTrials.gov ID: NCT01352416
Acronym / sponsor ID: 2009-101, IN-US-259-0114
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Keywords: Suppress Atrial Fibrillation, heart bypass surgery, heart valve surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of enrollment
Enrolment: 15 participants (actual)
Lead sponsor: Corewell Health EastUniversity, hospital or other
Collaborators: Beaumont Foundation of America, Gilead Sciences
Study start: Sep 2010
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 11 May 2011 (estimated)
Results: Posted 6 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
CABG surgery with Ranolazine	Active comparator	Drug: RanolazinePatient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Ranolazine 1000 mg (2-500mg tablets) twice daily. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg (1-500mg tablet) twice daily.
CABG surgery with placebo	Placebo comparator	Drug: PlaceboPatient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Placebo 1000mg mg (2-500mg tablets)twice daily. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily.
Heart Valve surgery with Ranolazine	Active comparator	Drug: RanolazinePatient will undergo heart Valve surgery and will receive, Ranolazine1000mg (2-500 mg tablets) twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg (1-500mg tablet) twice a day.
Heart Valve surgery with placebo	Placebo comparator	Drug: PlaceboPatient will undergo heart Valve surgery and will receive, Placebo 1000mg (2-500mg tablets) twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice a day.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.

Key exclusion criteria (9 listed)

Documented atrial fibrillation within the previous 3 months
Ongoing therapy with suppressive antiarrhythmic drugs
Patient currently on digoxin
Emergent surgery
Patient receiving hemodialysis

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: RanexaRanolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily	Drug	CABG surgery with Ranolazine, Heart Valve surgery with Ranolazine
PlaceboAlso: inactive ingredients pillPlacebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily	Drug	CABG surgery with placebo, Heart Valve surgery with placebo

Primary outcome

Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.
Time frame: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged
Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.

Results and safety

Results posted to the registry on 6 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ranolazine and Patients Having CABG Surgery	4	3
Sugar Pill and Patients Having CABG Surgery	7	5
Ranolazine With Patients Having Non CABG Heart Surgery	2	0
Sugar Pills and Patients Having Non CABG Heart Surgery	2	1

Primary outcome: Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.

Time frame: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged

Population analysed: Study was prematurely terminated. Data for this Outcome Measure were not collected

Adverse events

Time frame: All unexpected Adverse Events will be reported for the duration of the study. Subjects were followed and monitored for 30 days (duration of participation). Adverse events were collected for 2 years. Study was prematurely terminated.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranolazine and Patients Having Heart Bypass Surgery	0 of 4 (0%)	0 of 4 (0%)	Not reported
Placebo Pill and Patients Having Heart Bypass Surgery	0 of 7 (0%)	0 of 7 (0%)	Not reported
Ranolazine and Patients Having Non Heart Bypass Surgery	0 of 2 (0%)	0 of 2 (0%)	Not reported
Placebo Pill and Patients Having Non Heart Bypass Surgery	0 of 2 (0%)	0 of 2 (0%)	Not reported

Limitations and caveats (from the sponsor): Early termination due to lack of enrollment. 15 pts enrolled, 6 withdrawn due breathing tube not removed by 10 pm day of surgery. 1 withdrawn after day 3 as he was in afib and placed on amio. All pts were male.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Ilana Kutinsky, DO principal investigator

Corewell Health East

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 Heart; Dysfunction Postoperative, Cardiac Surgery, run by Corewell Health East 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 1 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 6 Jan 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 6 Jan 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?

Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period. (time frame: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01352416.

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 6 Jan 2017.