Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.
排除标准
- •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
研究组 & 干预措施
CABG surgery with Ranolazine
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.
干预措施: Ranolazine (Drug)
CABG surgery with placebo
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.
干预措施: Placebo (Drug)
Heart Valve surgery with Ranolazine
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.
干预措施: Ranolazine (Drug)
Heart Valve surgery with placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.
时间窗: 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.
次要结局
未报告次要终点
研究者
Ilana Kutinsky
Physician
William Beaumont Hospitals