Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

William Beaumont Hospitals

Status and phase: Terminated; Phase 3

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery

Treatments: Drug: Ranolazine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01352416

2009-101, IN-US-259-0114

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 22+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 4 patient groups, including a placebo group

CABG surgery with Ranolazine

Active Comparator group

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.

Treatment:

Drug: Ranolazine

CABG surgery with placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo

Heart Valve surgery with Ranolazine

Active Comparator group

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.

Treatment:

Drug: Ranolazine

Heart Valve surgery with placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo