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Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI) (RIVER-PCI)

Primary Purpose

Coronary Artery Disease, Angina Pectoris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent
  2. Males and females aged 18 years and older
  3. History of chronic angina defined as at least 2 episodes of anginal pain or discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which occurred on at least 2 separate days and at least 14 days prior to PCI (in the case of staged PCI procedures, at least 14 days prior to the first PCI in the series). Participants may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as any time prior to Randomization.

  4. PCI for any indication (ACS or non-ACS). For the purposes of stratification at randomization, ACS will be defined as hospitalization for anginal pain or discomfort within the previous 24 hours to their hospitalization with any one (or more) of the following criteria:

    i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with myocardial infarction (MI), as reported by local laboratory and measured prior to index PCI ii. Electrocardiographic changes (including transient changes) comprising new or presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle Branch Block

  5. Randomization within 14 days post-PCI. In the case of staged PCI procedures, randomization has to occur within 14 days of the last PCI in the series. Participants may be randomized starting on the day of PCI and anytime during the following 14 days. PCI is defined as an attempt to cross the lesion with a wire with the intention of performing revascularization.
  6. Post-PCI (post the last PCI for staged procedures) evidence of incomplete revascularization defined as the presence of one or more visually estimated ≥ 50% stenoses in one or more coronary arteries with reference vessel diameter of at least 2.0 mm, whether in the target vessel or in a non-target vessel regardless of the presence or absence of coronary collaterals. In the case of a participant post-coronary artery bypass grafting (CABG), incomplete revascularization is defined as the presence of one or more visually estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft supplying an otherwise unrevascularized myocardial territory.

  7. Clinically stable post-PCI. Participants randomized in-hospital on day of planned discharge or in clinic are considered stable. Participants randomized in-hospital prior to day of planned discharge must meet all of the following criteria:

    i. CK-MB < 3 times the upper limit of normal (ULN) at least 3 hours post-PCI, or if ≥ 3 times the ULN with evidence of decreasing CK-MB (decreased by at least 20% from the prior measurement) as reported by local laboratory. If CK-MB is not available, a participant must have evidence of normal or decreasing troponin levels (by at least 20% from the prior measurement) at least 3 hours post-PCI, as reported by local laboratory.

    ii. Systolic blood pressure ≥ 90 mm Hg and not receiving pressors or inotropes iii. No current requirement for an intra-aortic balloon pump (IABP) or any left ventricular assist device iv. No current requirement for intravenous (IV) nitroglycerin

  8. Ability and willingness to comply with all study procedures during the course of the study
  9. Females of childbearing potential must have a negative pregnancy test at Screening (unless surgically sterile or post-menopausal) and must agree to use highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.

Exclusion Criteria:

  1. Any future planned revascularization (including staged procedures) or possible planned revascularization (ie, planned stress test to assess the imminent need for additional revascularization). Future planned stress tests for purposes of monitoring are permitted but strongly discouraged. Participants may be enrolled after the last PCI in the staged series or once a decision is made not to perform a follow up PCI, as long as Randomization occurs within 14 days from the last PCI. If a participant has had a stress test post-PCI and prior to Randomization and no further intervention is planned, the participant may be enrolled within 14 days from the last PCI.
  2. Unrevascularized left main coronary artery stenosis ≥ 50%. Participants with a history of CABG to the left coronary system will be considered to have a revascularized left main if at least one graft is patent.

  3. Major complication during or after the index PCI (in the case of staged PCI, the last in the series) including:

    i. Major bleeding (TIMI Bleeding classification or any bleeding requiring blood transfusion of ≥ 2 units of red blood cells) ii. Coronary perforation requiring treatment iii. Procedural complication requiring surgery (including CABG or peripheral vascular surgery)

  4. Stroke within 90 days prior to Randomization, or any history of stroke with permanent major neurologic disability (eg, aphasia or significant motor dysfunction)
  5. Cardiogenic shock within 90 days prior to Randomization (transient decreases in blood pressure without clinical sequelae are not considered to be cardiogenic shock)
  6. New York Heart Association (NYHA) Class III or IV heart failure
  7. Severe renal insufficiency as assessed by an estimated glomerular filtration rate < 30 mL/min/1.73m2 using the 4 variable modification of diet in renal disease (MDRD) equation per local laboratory (based on the last available measurement prior to Randomization, collected within 1 month prior to the index PCI [in the case of staged PCI, the last in the series])
  8. Liver cirrhosis
  9. Use of Class Ia, Ic, or Class III antiarrhythmics, except for amiodarone
  10. Current treatment with strong inhibitors of CYP3A
  11. Current treatment with CYP3A4 inducers or P-gp inducers
  12. Participants taking > 20 mg simvastatin daily or > 40 mg lovastatin daily who cannot reduce the dose to 20 mg once daily for simvastatin or 40 mg once daily for lovastatin, or who cannot switch to another statin
  13. Participants taking greater than a total of 1000 mg daily of metformin who cannot reduce the dose to a maximum total of 1000 mg daily (additional anti-diabetic medications may be added as clinically indicated to allow participants to decrease their metformin dose and maintain glycemic control)
  14. Previous treatment with ranolazine for > 7 consecutive days within 30 days prior to Randomization, or known hypersensitivity or intolerance to ranolazine or to any of the excipients
  15. Participation in another investigational drug or investigational device study within 30 days prior to Randomization (participation in registries is allowed)
  16. Women who are pregnant or breast feeding
  17. Non-coronary artery disease comorbid conditions (eg, advanced malignancy, severe aortic stenosis) which are likely to result in death within 2 years of Randomization
  18. Any condition that in the opinion of the investigator would preclude compliance with the study protocol

Sites / Locations

  • Cardiology, PC
  • University of Alabama at Birmingham
  • Heart Center Research, LLC
  • Scottsdale Healthcare
  • Scottsdale Healthcare
  • University of California San Diego
  • Spectrum Clinical Research Institute, Inc
  • Veterans Affairs San Diego Healthcare System
  • John Muir Medical Center Concord Campus
  • South Denver Cardiology Associates, PC
  • Yale University School of Medicine
  • Cardiology Associates of Fairfield County, PC
  • Washington Hospital Center
  • Zasa Clinical Research
  • Cardiology Research Associates
  • Broward General Medical Center
  • University of Florida
  • Michigan Heart, PC
  • Jacksonville Heart Center
  • University of Florida Health Sciences Center-Jacksonville
  • East Coast Institute for Research
  • Mayo Clinic Jacksonville
  • Mount Sinai Medical Center
  • Florida Heart Institute
  • Cardiovascular Institute of Northwest Florida
  • Tallahassee Research Institute
  • Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
  • University of Chicago Medical Center
  • Gateway Cardiology, PC
  • Indiana Heart Physicians, Inc.
  • The Indiana Heart Hospital
  • Northwest Indiana Cardiovascular Physicians
  • Iowa Heart Center
  • Saint Joseph Cardiology Associates
  • Clinical Trials of America, Inc.
  • Clinical Trials of America, Inc.
  • Northeast Cardiology Associates
  • Baltimore Heart Associates
  • Union Memorial Hospital
  • Tufts Medical Center
  • Saint Elizabeth's Medical Center
  • Cape Cod Research Institute
  • Oakwood Hospital and Medical Center
  • Essentia Health
  • Minneapolis Heart Institute
  • Saint Cloud Hospital
  • Cardiology Associates of North Mississippi
  • Gateway Cardiology, PC
  • Saint John's Regional Medical Center
  • Dartmouth Hitchcock Medical Center
  • Holy Name Medical Center
  • New York Methodist Hospital
  • Buffalo Heart Group
  • SJH Cardiology Associates
  • Columbia University Medical Center
  • Hudson Valley Heart Center
  • Stony Brook University Medical Center
  • Central New York Cardiology
  • Westchester Medical Center
  • Buffalo Cardiology and Pulmonary Associates, PC
  • Asheville Cardiology Associates
  • Mid Carolina Cardiology
  • Veterans Affairs Medical Center, Duke University Medical Center
  • Carolina Cardiology Associates
  • Wake Heart Research
  • Ohio Health Research Institute
  • Cardiology Associates of Southeast Ohio, Inc.
  • Oklahoma City Veterans' Affairs Medical Center
  • South Oklahoma Heart Research
  • The Heart and Vascular Center
  • Central Bucks Cardiology
  • Saint Vincent Health Care Center
  • Veterans Administration Medical Center
  • Pinnacle Health System
  • Rhode Island Hospital
  • Research Associates of Jackson
  • University of Tennessee
  • Centennial Heart Cardiovascular Consultants, LLC
  • North Texas Healthcare System, Dept. of Veteran's Affairs
  • Humble Cardiology Associates
  • Gamma Medical Research Inc.
  • San Antonio Endovascular and Heart Institute
  • Victoria Heart and Vascular Center
  • Utah Cardiology, PC
  • University of Vermont Medical Center, Fletcher Allen Health Care
  • Sentara Cardiovascular Research Institute
  • Landesklinikum Sankt Pölten
  • Landeskrankenhaus Graz West
  • Innsbruck Universitaetsklinik
  • Allgemeines Krankenhaus der Stadt Linz
  • Medizinische Universität Wien
  • Wilhelminenspital der Stadt Wien
  • Ziekenhuis Netwerk Antwerpen Middelheim
  • Imelda Ziekenhuis
  • ZOL Genk, Campus Saint Jan
  • Algemeen Ziekenhuis Sint-Jan
  • Centre Hospitalier Universitaire Sart Tilman Liège
  • Royal Alexandra Hospital
  • University of Alberta Hospital
  • New Brunswick Heart Centre
  • Hamilton Health Sciences, General Site
  • Hamilton Health Sciences
  • Scarborough Cardiology Research Associates
  • Saint Michael's Hospital
  • University Health Network
  • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Montreal Heart Institute
  • Hôpital du Sacré-Coeur de Montréal
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • Centre Hospitalier Universitaire de Sherbrooke
  • Karlovarská krajská nemocnice a.s.
  • Krajská nemocnice Liberec a.s.
  • Fakultní nemocnice Brno
  • Fakultní nemocnice u sv. Anny v Brne
  • Fakultní nemocnice Olomouc
  • Fakultní nemocnice Královské Vinohrady
  • Všeobecná fakultní nemocnice v Praze
  • Fakultní Nemocnice v Motole
  • Hôpital Bichat-Claude Bernard
  • Hôpital Rangueil
  • Centre Hospitalier d'Arras
  • Centre Hospitalier d'Annecy
  • Groupe hospitalier La Pitié Salpêtrière
  • Universitätsklinikum Heidelberg
  • Kerckhoff-Klinik GmbH
  • Asklepios-Kliniken Langen
  • Städtische Kliniken Bielefeld gGmbH
  • Sankt Johannes Hospital
  • Kliniken Maria Hilf GmbH
  • Krankenhaus Der Barmherzigen Brüder Trier
  • Vivantes Klinikum im Friedrichshain
  • Kaplan Medical Center
  • HaEmek Medical Center
  • Barzilai Medical Center
  • Assaf Harofeh Medical Centre
  • Rambam Medical Center
  • Bnai Zion Medical Center
  • Edith Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Ein-Kerem Medical Centre
  • Meir Medical Center
  • Western Galilee Hospital
  • Hillel Yaffe Medical Center
  • Tel Aviv Souraski Medical Center
  • Sheba Medical Center
  • ZIV Medical Center
  • Ospedali Riuniti di Bergamo
  • Azienda Ospedaliera S. Sebastiano di Caserta
  • Azienda Ospedaliero-Universitaria Careggi
  • Azienda Ospedaliera Universitaria San Martino
  • Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele
  • Azienda Ospedaliera "Maggiore della Carita" di Novara
  • A.R.N.A.S. Civico G. Di Cristina Benfratelli
  • Azienda Ospedaliero Universitaria di Parma
  • Ospedale Civile SS Annunziata ASL 1
  • Catharina Ziekenhuis
  • TweeSteden Ziekenhuis
  • Academisch Medisch Centrum
  • Maasstad Ziekenhuis
  • Ziekenhuis Rijnstate Arnhem
  • 4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii
  • American Heart of Poland S.A.
  • American Heart of Poland S.A.
  • Szpital Uniwersytecki w Krakowie
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
  • Instytut Kardiologii
  • American Heart of Poland S.A.
  • American Heart of Poland S.A.
  • American Heart of Poland S.A.
  • American Heart of Poland S.A.
  • SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne
  • American Heart of Poland S.A.
  • American Heart of Poland S.A.
  • SPZOZ, Szpital Wojewódzki we Wloclawku
  • Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego
  • Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
  • SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
  • Altai Regional Cardiological Dispensary
  • Regional Clinical Hospital №3
  • Ural Institute of Cardiology
  • Cardiological Dispensary
  • Republic Clinical Hospital № 2
  • Research Institute for Complex Issues of Cardiovascular Diseases
  • Medical Center "Alliance"
  • Regional Clinical Hospital
  • National Research Center For Preventive Medicine
  • City Clinical Hospital # 23 n.a."Medsantrud"
  • City Clinical Hospital #15 named after O.M. Filatov
  • University Clinical Hospital #1
  • City Clinical Hospital n.a. S.P.Botkin
  • City Clinical Hospital #5
  • City Clinical Emergency Hospital # 2
  • Penza Regional Clinical Hospital n.a. N.N. Burdenko
  • Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov
  • Scientific and Research Institution Of Cardiology
  • Volgograd Regional Clinical Cardiological Center
  • Hospital Central de Asturias
  • Hospital Universitario de Bellvitge
  • Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital
  • Hospital General Universitario de Alicante
  • Hospital Vall d´Hebrón
  • Hospital Clinic I Provincial de Barcelona
  • Hospital Clínico San Carlos
  • Hospital Universitario La Paz
  • Hospital Clínico Universitario Virgen de la Victoria
  • Hospital Universitario Marques de Valdecilla
  • Hospital Clinico Universitario de Valencia
  • Universitetssjukhuset Örebro
  • Falu lasarett
  • Sahlgrenska Universitetsjukhuset
  • Karlstad Central Hospital
  • Uppsala University Hospital
  • Royal Sussex County Hospital
  • The James Cook University Hospital
  • Freeman Hospital
  • Ashford and Saint Peter's Hospital NHS Trust
  • Saint Richards Hospital
  • Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ranolazine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.

Secondary Outcome Measures

Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.

Full Information

First Posted
September 22, 2011
Last Updated
June 6, 2016
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01442038
Brief Title
Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
Acronym
RIVER-PCI
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects With a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention With Incomplete Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina Pectoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2651 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
Subjects will receive ranolazine 500 milligrams (mg) twice daily for 7 days, followed by 1000 mg administered orally twice daily for the duration of the study. Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive one tablet of matching placebo twice daily for 7 days, followed by two tablets of matching placebo twice daily for the duration of the study. Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy.
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
Description
Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame
Baseline through end of study (average 90 weeks)
Secondary Outcome Measure Information:
Title
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
Description
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame
Baseline through end of study (average 90 weeks)
Title
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
Description
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame
Baseline through end of study (average 90 weeks)
Title
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
Description
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame
Baseline through end of study (average 90 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Males and females aged 18 years and older History of chronic angina defined as at least 2 episodes of anginal pain or discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which occurred on at least 2 separate days and at least 14 days prior to PCI (in the case of staged PCI procedures, at least 14 days prior to the first PCI in the series). Participants may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as any time prior to Randomization. PCI for any indication (ACS or non-ACS). For the purposes of stratification at randomization, ACS will be defined as hospitalization for anginal pain or discomfort within the previous 24 hours to their hospitalization with any one (or more) of the following criteria: i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with myocardial infarction (MI), as reported by local laboratory and measured prior to index PCI ii. Electrocardiographic changes (including transient changes) comprising new or presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle Branch Block Randomization within 14 days post-PCI. In the case of staged PCI procedures, randomization has to occur within 14 days of the last PCI in the series. Participants may be randomized starting on the day of PCI and anytime during the following 14 days. PCI is defined as an attempt to cross the lesion with a wire with the intention of performing revascularization. Post-PCI (post the last PCI for staged procedures) evidence of incomplete revascularization defined as the presence of one or more visually estimated ≥ 50% stenoses in one or more coronary arteries with reference vessel diameter of at least 2.0 mm, whether in the target vessel or in a non-target vessel regardless of the presence or absence of coronary collaterals. In the case of a participant post-coronary artery bypass grafting (CABG), incomplete revascularization is defined as the presence of one or more visually estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft supplying an otherwise unrevascularized myocardial territory. Clinically stable post-PCI. Participants randomized in-hospital on day of planned discharge or in clinic are considered stable. Participants randomized in-hospital prior to day of planned discharge must meet all of the following criteria: i. CK-MB < 3 times the upper limit of normal (ULN) at least 3 hours post-PCI, or if ≥ 3 times the ULN with evidence of decreasing CK-MB (decreased by at least 20% from the prior measurement) as reported by local laboratory. If CK-MB is not available, a participant must have evidence of normal or decreasing troponin levels (by at least 20% from the prior measurement) at least 3 hours post-PCI, as reported by local laboratory. ii. Systolic blood pressure ≥ 90 mm Hg and not receiving pressors or inotropes iii. No current requirement for an intra-aortic balloon pump (IABP) or any left ventricular assist device iv. No current requirement for intravenous (IV) nitroglycerin Ability and willingness to comply with all study procedures during the course of the study Females of childbearing potential must have a negative pregnancy test at Screening (unless surgically sterile or post-menopausal) and must agree to use highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug. Exclusion Criteria: Any future planned revascularization (including staged procedures) or possible planned revascularization (ie, planned stress test to assess the imminent need for additional revascularization). Future planned stress tests for purposes of monitoring are permitted but strongly discouraged. Participants may be enrolled after the last PCI in the staged series or once a decision is made not to perform a follow up PCI, as long as Randomization occurs within 14 days from the last PCI. If a participant has had a stress test post-PCI and prior to Randomization and no further intervention is planned, the participant may be enrolled within 14 days from the last PCI. Unrevascularized left main coronary artery stenosis ≥ 50%. Participants with a history of CABG to the left coronary system will be considered to have a revascularized left main if at least one graft is patent. Major complication during or after the index PCI (in the case of staged PCI, the last in the series) including: i. Major bleeding (TIMI Bleeding classification or any bleeding requiring blood transfusion of ≥ 2 units of red blood cells) ii. Coronary perforation requiring treatment iii. Procedural complication requiring surgery (including CABG or peripheral vascular surgery) Stroke within 90 days prior to Randomization, or any history of stroke with permanent major neurologic disability (eg, aphasia or significant motor dysfunction) Cardiogenic shock within 90 days prior to Randomization (transient decreases in blood pressure without clinical sequelae are not considered to be cardiogenic shock) New York Heart Association (NYHA) Class III or IV heart failure Severe renal insufficiency as assessed by an estimated glomerular filtration rate < 30 mL/min/1.73m2 using the 4 variable modification of diet in renal disease (MDRD) equation per local laboratory (based on the last available measurement prior to Randomization, collected within 1 month prior to the index PCI [in the case of staged PCI, the last in the series]) Liver cirrhosis Use of Class Ia, Ic, or Class III antiarrhythmics, except for amiodarone Current treatment with strong inhibitors of CYP3A Current treatment with CYP3A4 inducers or P-gp inducers Participants taking > 20 mg simvastatin daily or > 40 mg lovastatin daily who cannot reduce the dose to 20 mg once daily for simvastatin or 40 mg once daily for lovastatin, or who cannot switch to another statin Participants taking greater than a total of 1000 mg daily of metformin who cannot reduce the dose to a maximum total of 1000 mg daily (additional anti-diabetic medications may be added as clinically indicated to allow participants to decrease their metformin dose and maintain glycemic control) Previous treatment with ranolazine for > 7 consecutive days within 30 days prior to Randomization, or known hypersensitivity or intolerance to ranolazine or to any of the excipients Participation in another investigational drug or investigational device study within 30 days prior to Randomization (participation in registries is allowed) Women who are pregnant or breast feeding Non-coronary artery disease comorbid conditions (eg, advanced malignancy, severe aortic stenosis) which are likely to result in death within 2 years of Randomization Any condition that in the opinion of the investigator would preclude compliance with the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian McNabb, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Spectrum Clinical Research Institute, Inc
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92553
Country
United States
Facility Name
Veterans Affairs San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
John Muir Medical Center Concord Campus
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
South Denver Cardiology Associates, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Cardiology Associates of Fairfield County, PC
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Zasa Clinical Research
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Cardiology Research Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Michigan Heart, PC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Jacksonville Heart Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida Health Sciences Center-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
East Coast Institute for Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Heart Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Cardiovascular Institute of Northwest Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Gateway Cardiology, PC
City
Jerseyville
State/Province
Illinois
ZIP/Postal Code
62052
Country
United States
Facility Name
Indiana Heart Physicians, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
The Indiana Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Northwest Indiana Cardiovascular Physicians
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Iowa Heart Center
City
West De Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Saint Joseph Cardiology Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Minden
State/Province
Louisiana
ZIP/Postal Code
71055
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Northeast Cardiology Associates
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Baltimore Heart Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Saint Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Cape Cod Research Institute
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Essentia Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Saint Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Cardiology Associates of North Mississippi
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Gateway Cardiology, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Saint John's Regional Medical Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Buffalo Heart Group
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
SJH Cardiology Associates
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Hudson Valley Heart Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Central New York Cardiology
City
Utica
State/Province
New York
ZIP/Postal Code
13501
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Buffalo Cardiology and Pulmonary Associates, PC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Mid Carolina Cardiology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Veterans Affairs Medical Center, Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Carolina Cardiology Associates
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Heart Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Cardiology Associates of Southeast Ohio, Inc.
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Oklahoma City Veterans' Affairs Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
South Oklahoma Heart Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
The Heart and Vascular Center
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Central Bucks Cardiology
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Saint Vincent Health Care Center
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16502
Country
United States
Facility Name
Veterans Administration Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Pinnacle Health System
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Research Associates of Jackson
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
North Texas Healthcare System, Dept. of Veteran's Affairs
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Humble Cardiology Associates
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Gamma Medical Research Inc.
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
San Antonio Endovascular and Heart Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Victoria Heart and Vascular Center
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Utah Cardiology, PC
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
University of Vermont Medical Center, Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Landesklinikum Sankt Pölten
City
Saint Pölten
State/Province
Lower Austria
ZIP/Postal Code
3100
Country
Austria
Facility Name
Landeskrankenhaus Graz West
City
Graz
State/Province
Styria
ZIP/Postal Code
8020
Country
Austria
Facility Name
Innsbruck Universitaetsklinik
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
State/Province
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital der Stadt Wien
City
Wien
State/Province
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerp
State/Province
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
State/Province
Antwerpen
ZIP/Postal Code
2820
Country
Belgium
Facility Name
ZOL Genk, Campus Saint Jan
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Sart Tilman Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
New Brunswick Heart Centre
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Hamilton Health Sciences, General Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Scarborough Cardiology Research Associates
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1E 5E9
Country
Canada
Facility Name
Saint Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Karlovarská krajská nemocnice a.s.
City
Karlovy Vary
State/Province
Karlovarský kraj
ZIP/Postal Code
360 66
Country
Czech Republic
Facility Name
Krajská nemocnice Liberec a.s.
City
Liberec
State/Province
Liberecký kraj
ZIP/Postal Code
460 63
Country
Czech Republic
Facility Name
Fakultní nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Fakultní nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
Fakultní nemocnice Olomouc
City
Olomoucký kraj
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Fakultní nemocnice Královské Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Všeobecná fakultní nemocnice v Praze
City
Praha
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Fakultní Nemocnice v Motole
City
Praha
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Hôpital Bichat-Claude Bernard
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75018
Country
France
Facility Name
Hôpital Rangueil
City
Toulouse Cedex 9
State/Province
Midi-Pyrenees
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier d'Arras
City
Arras
State/Province
Nord Pas-De-Calais
ZIP/Postal Code
62022
Country
France
Facility Name
Centre Hospitalier d'Annecy
City
Pringy
State/Province
Rhone-Alpes
ZIP/Postal Code
74374
Country
France
Facility Name
Groupe hospitalier La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Facility Name
Asklepios-Kliniken Langen
City
Langen
State/Province
Hessen
ZIP/Postal Code
63225
Country
Germany
Facility Name
Städtische Kliniken Bielefeld gGmbH
City
Bielefeld
State/Province
Nordrhein-westfalen
ZIP/Postal Code
33604
Country
Germany
Facility Name
Sankt Johannes Hospital
City
Dortmund
State/Province
Nordrhein-westfalen
ZIP/Postal Code
44137
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
State/Province
Nordrhein-westfalen
ZIP/Postal Code
41063
Country
Germany
Facility Name
Krankenhaus Der Barmherzigen Brüder Trier
City
Trier
State/Province
Rheinland-pfalz
ZIP/Postal Code
54292
Country
Germany
Facility Name
Vivantes Klinikum im Friedrichshain
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Kaplan Medical Center
City
Rehovot
State/Province
Reheoboth
ZIP/Postal Code
76100
Country
Israel
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78287
Country
Israel
Facility Name
Assaf Harofeh Medical Centre
City
Beer Yahkov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
33394
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Ein-Kerem Medical Centre
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Western Galilee Hospital
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Tel Aviv Souraski Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
ZIV Medical Center
City
Zafed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Azienda Ospedaliera S. Sebastiano di Caserta
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera "Maggiore della Carita" di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
A.R.N.A.S. Civico G. Di Cristina Benfratelli
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Civile SS Annunziata ASL 1
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Noord-brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
TweeSteden Ziekenhuis
City
Tilburg
State/Province
Noord-brabant
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid-holland
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate Arnhem
City
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-981
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Belchatów
State/Province
Lodzkie
ZIP/Postal Code
97-400
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Chrzanów
State/Province
Malopolskie
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Instytut Kardiologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Kedzierzyn Kozle
State/Province
Opolskie
ZIP/Postal Code
47-200
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Mielec
State/Province
Podkarpackie
ZIP/Postal Code
39-300
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Bielsko-Biala
State/Province
Slaskie
ZIP/Postal Code
43-316
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Dabrowa Górnicza
State/Province
Slaskie
ZIP/Postal Code
41-300
Country
Poland
Facility Name
SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-635
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
American Heart of Poland S.A.
City
Ustron
State/Province
Slaskie
ZIP/Postal Code
43-450
Country
Poland
Facility Name
SPZOZ, Szpital Wojewódzki we Wloclawku
City
Kujawsko-pomorskie
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Altai Regional Cardiological Dispensary
City
Barnaul
ZIP/Postal Code
656055
Country
Russian Federation
Facility Name
Regional Clinical Hospital №3
City
Chelyabinsk
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
Ural Institute of Cardiology
City
Ekaterinburg
ZIP/Postal Code
620144
Country
Russian Federation
Facility Name
Cardiological Dispensary
City
Ivanovo
ZIP/Postal Code
153012
Country
Russian Federation
Facility Name
Republic Clinical Hospital № 2
City
Kazan
ZIP/Postal Code
420043
Country
Russian Federation
Facility Name
Research Institute for Complex Issues of Cardiovascular Diseases
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Medical Center "Alliance"
City
Kirovsk, Leningradskaya Region
ZIP/Postal Code
187342
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
National Research Center For Preventive Medicine
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
City Clinical Hospital # 23 n.a."Medsantrud"
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
City Clinical Hospital #15 named after O.M. Filatov
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
University Clinical Hospital #1
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
City Clinical Hospital n.a. S.P.Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
City Clinical Hospital #5
City
Nizhni Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
City Clinical Emergency Hospital # 2
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Penza Regional Clinical Hospital n.a. N.N. Burdenko
City
Penza
ZIP/Postal Code
444026
Country
Russian Federation
Facility Name
Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Scientific and Research Institution Of Cardiology
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Cardiological Center
City
Volgograd
ZIP/Postal Code
400008
Country
Russian Federation
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
L´Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36214
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Vall d´Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Universitetssjukhuset Örebro
City
Örebro
State/Province
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Falu lasarett
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Sahlgrenska Universitetsjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Karlstad Central Hospital
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
The James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Ashford and Saint Peter's Hospital NHS Trust
City
Surrey
State/Province
England
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
West Sussex
State/Province
England
ZIP/Postal Code
PO19 6SE
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Northern Ireland
ZIP/Postal Code
BT12 6BA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24268208
Citation
Weisz G, Farzaneh-Far R, Ben-Yehuda O, Debruyne B, Montalescot G, Lerman A, Mahmud E, Alexander KP, Ohman EM, White HD, Olmsted A, Walker GA, Stone GW. Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (RIVER-PCI) trial. Am Heart J. 2013 Dec;166(6):953-959.e3. doi: 10.1016/j.ahj.2013.08.004. Epub 2013 Oct 16.
Results Reference
background
PubMed Identifier
26474810
Citation
Weisz G, Genereux P, Iniguez A, Zurakowski A, Shechter M, Alexander KP, Dressler O, Osmukhina A, James S, Ohman EM, Ben-Yehuda O, Farzaneh-Far R, Stone GW; RIVER-PCI investigators. Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Jan 9;387(10014):136-45. doi: 10.1016/S0140-6736(15)00459-6. Epub 2015 Oct 22.
Results Reference
result
PubMed Identifier
26555329
Citation
Alexander KP, Weisz G, Prather K, James S, Mark DB, Anstrom KJ, Davidson-Ray L, Witkowski A, Mulkay AJ, Osmukhina A, Farzaneh-Far R, Ben-Yehuda O, Stone GW, Ohman EM. Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial. Circulation. 2016 Jan 5;133(1):39-47. doi: 10.1161/CIRCULATIONAHA.115.019768. Epub 2015 Nov 10.
Results Reference
result
PubMed Identifier
30771861
Citation
Fanaroff AC, Prather K, Brucker A, Wojdyla D, Davidson-Ray L, Mark DB, Williams RB, Barefoot J, Weisz G, Ben-Yehuda O, Stone GW, Ohman EM, Alexander KP. Relationship Between Optimism and Outcomes in Patients With Chronic Angina Pectoris. Am J Cardiol. 2019 May 1;123(9):1399-1405. doi: 10.1016/j.amjcard.2019.01.036. Epub 2019 Feb 7.
Results Reference
derived

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Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)

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