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Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

This study has been terminated.
(lack of enrollment)
Sponsor:
Collaborators:
Beaumont Foundation of America
Gilead Sciences
Information provided by (Responsible Party):
Ilana Kutinsky, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01352416
First received: May 4, 2011
Last updated: November 8, 2016
Last verified: November 2016
  Purpose
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

Condition Intervention Phase
Heart; Dysfunction Postoperative, Cardiac Surgery Drug: Ranolazine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Ilana Kutinsky, William Beaumont Hospitals:

Primary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: September 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Ranolazine
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
Other Name: Ranexa
Placebo Comparator: 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.
Drug: Placebo
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
Other Name: inactive ingredients pill
Active Comparator: 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.
Drug: Ranolazine
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
Other Name: Ranexa
Placebo Comparator: 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.
Drug: Placebo
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
Other Name: inactive ingredients pill

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.
  Eligibility

Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352416

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital
Troy, Michigan, United States, 48085-1198
Sponsors and Collaborators
William Beaumont Hospitals
Beaumont Foundation of America
Gilead Sciences
Investigators
Principal Investigator: Ilana Kutinsky, DO William Beaumont Hospitals
  More Information

Responsible Party: Ilana Kutinsky, Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01352416     History of Changes
Other Study ID Numbers: 2009-101, IN-US-259-0114
Study First Received: May 4, 2011
Results First Received: June 14, 2016
Last Updated: November 8, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ilana Kutinsky, William Beaumont Hospitals:
Suppress Atrial Fibrillation
heart bypass surgery
heart valve surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ranolazine
Verapamil
Diltiazem
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 21, 2017