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Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Primary Purpose

Heart; Dysfunction Postoperative, Cardiac Surgery

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart; Dysfunction Postoperative, Cardiac Surgery focused on measuring Suppress Atrial Fibrillation, heart bypass surgery, heart valve surgery

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • William Beaumont Hospital
  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

CABG surgery with Ranolazine

CABG surgery with placebo

Heart Valve surgery with Ranolazine

Heart Valve surgery with placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2011
Last Updated
November 8, 2016
Sponsor
William Beaumont Hospitals
Collaborators
Beaumont Foundation of America, Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01352416
Brief Title
Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
Official Title
Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
Collaborators
Beaumont Foundation of America, Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart; Dysfunction Postoperative, Cardiac Surgery
Keywords
Suppress Atrial Fibrillation, heart bypass surgery, heart valve surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CABG surgery with Ranolazine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CABG surgery with placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Heart Valve surgery with Ranolazine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Heart Valve surgery with placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
inactive ingredients pill
Intervention Description
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
Primary Outcome Measure Information:
Title
Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.
Description
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.
Time Frame
The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent. Exclusion Criteria: 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 Known tolerance or hypersensitivity to ranolazine Pregnant individuals MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Kutinsky, DO
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085-1198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

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