Ranolazine Implantable Cardioverter-Defibrillator Trial
RAID
Late Sodium Current Blockade in High-Risk ICD Patients
1 other identifier
interventional
1,012
2 countries
90
Brief Summary
The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is routinely prescribed in enrolled patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
Longer than P75 for phase_3
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2010
CompletedFirst Posted
Study publicly available on registry
October 6, 2010
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedResults Posted
Study results publicly available
June 15, 2018
CompletedAugust 27, 2018
July 1, 2018
5.5 years
September 30, 2010
May 24, 2018
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death
Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring antitachycardia pacing (ATP) therapy, implantable cardioverter-defibrillator (ICD) shock, or death, whichever occurs first.
2 years of follow-up on average
Secondary Outcomes (9)
Number of Patients With VT or VF Requiring ICD Shock or Death
2 years of follow-up on average
Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies
2 years of follow-up on average
Number of Patients With First Inappropriate ICD Shock
2 years of follow-up on average
Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First.
2 years of follow-up on average
Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First
2 years of follow-up on average
- +4 more secondary outcomes
Other Outcomes (2)
Number of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP)
2 years of follow-up on average
Number of Patients Whose First VT/VF Required ICD Shock
2 years of follow-up on average
Study Arms (2)
Ranolazine
ACTIVE COMPARATORAt enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl \<60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if \<30ml/min. For patients with CrCl \<60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if \<30ml/min.
Placebo
PLACEBO COMPARATORAt enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl \<60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if \<30ml/min. For patients with CrCl \<60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if \<30ml/min.
Interventions
At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Eligibility Criteria
You may qualify if:
- ,440 high-risk patients with ischemic/nonischemic cardiomyopathy who receive their ICDs as standard of care for primary or secondary prevention of mortality following approved indications for ICD therapy. High-risk patients will be defined as:
- Secondary Prevention Patients Subjects with ischemic or nonischemic cardiomyopathy, qualified for or with existing ICD (or CRT-D) after documented VT/VF or cardiac arrest (secondary prevention of mortality). Secondary prevention subjects with existing implants are eligible regardless of when the implant was received (subjects could be recruited from outpatient clinics or from inpatient activity including during re-implant or other procedures).
- Primary Prevention Patients
- Patients with primary prevention indications for ischemic or non-ischemic cardiomyopathy with EF≤35%, with existing devices (ICD/CRT-D), regardless of when the device was implanted, who have experienced at least ONE episode of VT/VF appropriately treated with ICD therapy (ATP or shock) or had untreated NSVT lasting at least 10 beats with heart rate of at least 170 bpm, documented by electrogram of their implanted device.
- Patients with ischemic or non-ischemic cardiomyopathy with EF≤35%, who have been implanted within the last 2 years (initial ICD/CRT-D implants, including upgrades from pacemakers) who have NOT experienced VT/VF treated with ICD therapy (ATP or shock), AND who have one of the following additional criteria: BUN≥26 mg/dl or QRS\>120ms or Atrial Fibrillation or NSVT documented by ECG/Holter or \>500 Ventricular Premature Beats (VPBs)documented in a 24-hour Holter.
- Stable optimal pharmacologic therapy for the cardiac condition
- Age: equal to 21 years without upper limit
You may not qualify if:
- Patient receiving first device with coronary artery bypass graft surgery within the last 3 calendar months prior to date consent obtained
- Patients receiving first device with percutaneous coronary intervention within the last 1 calendar month prior to date consent obtained
- Patient receiving first device with enzyme-positive myocardial infarction with the past 3 calendar months prior to date consent obtained
- Patient receiving first device with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
- Patient in NYHA Class IV
- Patients receiving prophylactic ablation of ventricular substrate
- Patients with preexisting QTc prolongation \>550ms
- Patients on strong CYP3A inhibitors (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir and moderate CYP3A inhibitors, including, diltiazem, verapamil, aprepitant, erythromycin, fluconazole and grapefruit juice or grapefruit-containing products.
- Patients on CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort
- Patients with inherited arrhythmia disorders such as Brugada's, ARVD, LQTS or hypertrophic cardiomyopathy
- Patient who is pregnant or plans to become pregnant during the course of the trial (patients at child bearing age who use prescribed pharmaceutical contraceptives could be enrolled)
- Patient with irreversible brain damage from preexisting cerebral disease
- Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
- Patient with chronic renal disease with creatinine \>2.5 mg/dl or creatinine clearance \<30 ml/min
- Patient participating in any other clinical trial
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
University of Arizona
Tucson, Arizona, 85724, United States
Arkansas Cardiology
Little Rock, Arkansas, 72205, United States
Sequoia Hospital
East Palo Alto, California, 94303, United States
Good Samaritan Hospital
Los Angeles, California, 90017, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Regional Cardiology Associates
Sacramento, California, 95819, United States
Delta Heart and Medical Clinic
Stockton, California, 95210, United States
University of Colorado Health - MHS
Colorado Springs, Colorado, 80909, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Washington Electrophysiology/Cardiovascular Research Institute
Washington D.C., District of Columbia, 20010, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511, United States
University of Florida/Cardiovascular Medicine
Gainesville, Florida, 32610, United States
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, 32209, United States
Watson Clincia Center for Research Inc.
Lakeland, Florida, 33805, United States
Florida Hospital
Orlando, Florida, 32803, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308, United States
Georgia Health Sciences University
Augusta, Georgia, 30912, United States
Georgia Arrhythmia Consultants
Macon, Georgia, 31201, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Peakview Research Center
Fort Wayne, Indiana, 46845, United States
LaPorte Hospital
Hobart, Indiana, 46342, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Louisiana State University Health Sciences Center- New Orleans
New Orleans, Louisiana, 70112, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735, United States
Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Massachusetts-Worchester
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
St. Luke's Hospital Association of Duluth
Duluth, Minnesota, 55805, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri
Columbia, Missouri, 65212, United States
Kansas City Heart Foundation
Kansas City, Missouri, 64114, United States
Cooper University Hospital
Camden, New Jersey, 08043, United States
Morristown Memorial Hospital- Gagnon Cardiovascular Institute
Morristown, New Jersey, 07962, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10021, United States
St. Luke's-Roosevelt Hospital
New York, New York, 10025, United States
Hudson Valley Heart Center
Poughkeepsie, New York, 12601, United States
The Valley Hospital
Ridgewood, New York, 07450, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center,
Stony Brook, New York, 11794, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Lindner Center for Research & Education
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
The MetroHealth System - Heart and Vascular Dept.
Cleveland, Ohio, 44109, United States
The Toledo Hospital/Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43615, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Portland VA Medical Ctr
Portland, Oregon, 97239, United States
Abington Medical Specialists
Abington, Pennsylvania, 19001, United States
Doylestown Cardiology Associates - VIAA
Doylestown, Pennsylvania, 18901, United States
Doylestown Health Cardiology/Central Bucks
Doylestown, Pennsylvania, 18901, United States
Lancaster Heart & Stroke Foundation
Lancaster, Pennsylvania, 17602, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center-Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
VA Pittsburgh Healthcare Center
Pittsburgh, Pennsylvania, 15240, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
Brigham and Women's Cardiovascular Associates
Warwick, Rhode Island, 02886, United States
The Stern Cardiovascular Center
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Cardiopulmonary Research Science and Technology Inst.
Dallas, Texas, 75230, United States
Medicus Alliance CRO, Inc
Houston, Texas, 77090, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Cardiovascular Associates Ltd.
Chesapeake, Virginia, 23320, United States
Walter Reed NMMC
Portsmouth, Virginia, 20889, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Kootenai Heart Clinics, LLC
Spokane, Washington, 99204, United States
Cardiac Study Center
Tacoma, Washington, 98405, United States
CAMC Institute
Charleston, West Virginia, 25304, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Wheaton Franciscan All Saints
Racine, Wisconsin, 53402, United States
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Queen's University
Kingston, Ontario, K7L 2V7, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
McGill University Health Centre
Montreal, Quebec, H3G1A4, Canada
CHUS (Sherbrooke University)
Sherbrooke, Quebec, J1H5N4, Canada
IUCPQ
Québec, G1V 4G5, Canada
Related Publications (3)
Krzowski B, Kutyifa V, Vloka M, Huang DT, Attari M, Aktas M, Shah AH, Musat D, Rosenthal L, McNitt S, Polonsky B, Schuger C, Natale A, Ziv O, Beck C, Daubert JP, Goldenberg I, Zareba W. Sex-Related Differences in Ventricular Tachyarrhythmia Events in Patients With Implantable Cardioverter-Defibrillator and Prior Ventricular Tachyarrhythmias. JACC Clin Electrophysiol. 2024 Feb;10(2):284-294. doi: 10.1016/j.jacep.2023.09.028. Epub 2023 Nov 29.
PMID: 38032582DERIVEDYounis A, Goldenberg I, Farooq S, Yavin H, Daubert J, Raitt M, Mazur A, Huang DT, Mitchell BL, Rashtian MR, Winters S, Vloka M, Aktas M, Bernabei MA, Beck CA, McNitt S, Zareba W. Reduction in Ventricular Tachyarrhythmia Burden in Patients Enrolled in the RAID Trial. JACC Clin Electrophysiol. 2022 Jun;8(6):754-762. doi: 10.1016/j.jacep.2022.02.018. Epub 2022 Apr 27.
PMID: 35738852DERIVEDZareba W, Daubert JP, Beck CA, Huang DT, Alexis JD, Brown MW, Pyykkonen K, McNitt S, Oakes D, Feng C, Aktas MK, Ayala-Parades F, Baranchuk A, Dubuc M, Haigney M, Mazur A, McPherson CA, Mitchell LB, Natale A, Piccini JP, Raitt M, Rashtian MY, Schuger C, Winters S, Worley SJ, Ziv O, Moss AJ; RAID Trial Investigators. Ranolazine in High-Risk Patients With Implanted Cardioverter-Defibrillators: The RAID Trial. J Am Coll Cardiol. 2018 Aug 7;72(6):636-645. doi: 10.1016/j.jacc.2018.04.086.
PMID: 30071993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wojciech Zareba
- Organization
- University of Rochester
Study Officials
- PRINCIPAL INVESTIGATOR
Wojciech Zareba, MD PhD
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
September 30, 2010
First Posted
October 6, 2010
Study Start
September 1, 2011
Primary Completion
February 28, 2017
Study Completion
February 28, 2017
Last Updated
August 27, 2018
Results First Posted
June 15, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share
The RAID PI and Steering Committee with investigators from enrolling sites have designed a series of secondary substudies that will be disseminated as abstracts and manuscripts. External proposal of analyses of the RAID trial data will be reviewed bye the Steering Committee and analyses will be conducted by the Data Coordinating Center (DCC) of the trial.