Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Phase 3TerminatedNCT01352416

Corewell Health East15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Interventions

RanolazineDRUG

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

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

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (2)

William Beaumont Hospital

Royal Oak, Michigan, United States

William Beaumont Hospital

Troy, Michigan, United States

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

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