Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
RIVER-PCI
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
2 other identifiers
interventional
2,651
15 countries
218
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Oct 2011
Typical duration for phase_3 coronary-artery-disease
218 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 22, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
July 15, 2016
CompletedJuly 15, 2016
June 1, 2016
3.3 years
September 22, 2011
February 9, 2016
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline through end of study (average 90 weeks)
Secondary Outcomes (3)
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
Baseline through end of study (average 90 weeks)
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
Baseline through end of study (average 90 weeks)
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
Baseline through end of study (average 90 weeks)
Study Arms (2)
Ranolazine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (218)
Cardiology, PC
Birmingham, Alabama, 35211, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85251, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
University of California San Diego
La Jolla, California, 92037, United States
Spectrum Clinical Research Institute, Inc
Moreno Valley, California, 92553, United States
Veterans Affairs San Diego Healthcare System
San Diego, California, 92161, United States
John Muir Medical Center Concord Campus
Walnut Creek, California, 94598, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Cardiology Associates of Fairfield County, PC
Stamford, Connecticut, 06905, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Zasa Clinical Research
Atlantis, Florida, 33462, United States
Cardiology Research Associates
Daytona Beach, Florida, 32117, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
University of Florida
Gainesville, Florida, 32610, United States
Michigan Heart, PC
Hialeah, Florida, 33010, United States
Jacksonville Heart Center
Jacksonville, Florida, 32207, United States
University of Florida Health Sciences Center-Jacksonville
Jacksonville, Florida, 32209, United States
East Coast Institute for Research
Jacksonville, Florida, 32216, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Heart Institute
Orlando, Florida, 32803, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32401, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
Tampa, Florida, 33613, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Gateway Cardiology, PC
Jerseyville, Illinois, 62052, United States
Indiana Heart Physicians, Inc.
Indianapolis, Indiana, 46237, United States
The Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
Northwest Indiana Cardiovascular Physicians
Valparaiso, Indiana, 46383, United States
Iowa Heart Center
West de Moines, Iowa, 50266, United States
Saint Joseph Cardiology Associates
Lexington, Kentucky, 40504, United States
Clinical Trials of America, Inc.
Minden, Louisiana, 71055, United States
Clinical Trials of America, Inc.
Shreveport, Louisiana, 71103, United States
Northeast Cardiology Associates
Bangor, Maine, 04401, United States
Baltimore Heart Associates
Baltimore, Maryland, 21215, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Saint Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Cape Cod Research Institute
Hyannis, Massachusetts, 02601, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
Essentia Health
Duluth, Minnesota, 55805, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801, United States
Saint John's Regional Medical Center
Springfield, Missouri, 65804, United States
Gateway Cardiology, PC
St Louis, Missouri, 63128, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Buffalo Heart Group
Buffalo, New York, 14215, United States
SJH Cardiology Associates
Liverpool, New York, 13088, United States
Columbia University Medical Center
New York, New York, 10032, United States
Hudson Valley Heart Center
Poughkeepsie, New York, 12601, United States
Stony Brook University Medical Center
Stony Brook, New York, 11790, United States
Central New York Cardiology
Utica, New York, 13501, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Buffalo Cardiology and Pulmonary Associates, PC
Williamsville, New York, 14221, United States
Asheville Cardiology Associates
Asheville, North Carolina, 28803, United States
Mid Carolina Cardiology
Charlotte, North Carolina, 28204, United States
Veterans Affairs Medical Center, Duke University Medical Center
Durham, North Carolina, 27705, United States
Carolina Cardiology Associates
High Point, North Carolina, 27262, United States
Wake Heart Research
Raleigh, North Carolina, 27610, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Cardiology Associates of Southeast Ohio, Inc.
Zanesville, Ohio, 43701, United States
Oklahoma City Veterans' Affairs Medical Center
Oklahoma City, Oklahoma, 73104, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135, United States
The Heart and Vascular Center
Beaver, Pennsylvania, 15009, United States
Central Bucks Cardiology
Doylestown, Pennsylvania, 18901, United States
Saint Vincent Health Care Center
Erie, Pennsylvania, 16502, United States
Veterans Administration Medical Center
Pittsburgh, Pennsylvania, 15240, United States
Pinnacle Health System
Wormleysburg, Pennsylvania, 17043, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Research Associates of Jackson
Jackson, Tennessee, 38301, United States
University of Tennessee
Knoxville, Tennessee, 37920, United States
Centennial Heart Cardiovascular Consultants, LLC
Nashville, Tennessee, 37203, United States
North Texas Healthcare System, Dept. of Veteran's Affairs
Dallas, Texas, 75216, United States
Humble Cardiology Associates
Humble, Texas, 77338, United States
Gamma Medical Research Inc.
Mission, Texas, 78572, United States
San Antonio Endovascular and Heart Institute
San Antonio, Texas, 78258, United States
Victoria Heart and Vascular Center
Victoria, Texas, 77901, United States
Utah Cardiology, PC
Layton, Utah, 84041, United States
University of Vermont Medical Center, Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Landesklinikum Sankt Pölten
Sankt Pölten, Lower Austria, 3100, Austria
Landeskrankenhaus Graz West
Graz, Styria, 8020, Austria
Innsbruck Universitaetsklinik
Innsbruck, Tyrol, 6020, Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, Upper Austria, 4020, Austria
Medizinische Universität Wien
Vienna, Vienna, 1090, Austria
Wilhelminenspital der Stadt Wien
Vienna, Vienna, 1160, Austria
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, Antwerpen, 2020, Belgium
Imelda Ziekenhuis
Bonheiden, Antwerpen, 2820, Belgium
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, Liege, 4000, Belgium
ZOL Genk, Campus Saint Jan
Genk, Limburg, 3600, Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges, West-Vlaanderen, 8000, Belgium
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
New Brunswick Heart Centre
Saint John, New Brunswick, E2L 4L2, Canada
Hamilton Health Sciences, General Site
Hamilton, Ontario, L8L 2X2, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
Scarborough Cardiology Research Associates
Scarborough Village, Ontario, M1E 5E9, Canada
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2W 1T8, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Karlovarská krajská nemocnice a.s.
Karlovy Vary, Karlovarský kraj, 360 66, Czechia
Krajská nemocnice Liberec a.s.
Liberec, Liberecký kraj, 460 63, Czechia
Fakultní nemocnice Brno
Brno, 625 00, Czechia
Fakultní nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Fakultní nemocnice Olomouc
Olomoucký Kraj, 775 20, Czechia
Fakultní nemocnice Královské Vinohrady
Prague, 100 34, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, 128 08, Czechia
Fakultní Nemocnice v Motole
Prague, 150 06, Czechia
Centre Hospitalier d'Annecy
Pringy, Auvergne-Rhône-Alpes, 74374, France
Centre Hospitalier d'Arras
Arras, Hauts-de-France, 62022, France
Hôpital Rangueil
Toulouse, Midi-Pyrenees, 31059, France
Groupe hospitalier La Pitié Salpêtrière
Paris, 75013, France
Hôpital Bichat-Claude Bernard
Paris, Île-de-France Region, 75018, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Hesse, 61231, Germany
Asklepios-Kliniken Langen
Langen, Hesse, 63225, Germany
Städtische Kliniken Bielefeld gGmbH
Bielefeld, North Rhine-Westphalia, 33604, Germany
Sankt Johannes Hospital
Dortmund, North Rhine-Westphalia, 44137, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
Krankenhaus Der Barmherzigen Brüder Trier
Trier, Rhineland-Palatinate, 54292, Germany
Vivantes Klinikum im Friedrichshain
Berlin, State of Berlin, 10249, Germany
Kaplan Medical Center
Rehovot, Reheoboth, 76100, Israel
HaEmek Medical Center
Afula, 18101, Israel
Barzilai Medical Center
Ashkelon, 78287, Israel
Assaf Harofeh Medical Centre
Beer Yahkov, 70300, Israel
Rambam Medical Center
Haifa, 31096, Israel
Bnai Zion Medical Center
Haifa, 33394, Israel
Edith Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Ein-Kerem Medical Centre
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Western Galilee Hospital
Nahariya, 22100, Israel
Hillel Yaffe Medical Center
Ramat Gan, Israel
Tel Aviv Souraski Medical Center
Tel Aviv, 64239, Israel
Sheba Medical Center
Tel Litwinsky, 52621, Israel
ZIV Medical Center
Zafed, 13100, Israel
Ospedali Riuniti di Bergamo
Bergamo, Bergamo, 24128, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Firenze, 50134, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Genova, 16132, Italy
Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele
Milan, Milano, 20132, Italy
Ospedale Civile SS Annunziata ASL 1
Sassari, Sassari, 07100, Italy
Azienda Ospedaliera S. Sebastiano di Caserta
Caserta, 81100, Italy
Azienda Ospedaliera "Maggiore della Carita" di Novara
Novara, 28100, Italy
A.R.N.A.S. Civico G. Di Cristina Benfratelli
Palermo, 90127, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, 43100, Italy
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ, Netherlands
TweeSteden Ziekenhuis
Tilburg, North Brabant, 5042 AD, Netherlands
Academisch Medisch Centrum
Amsterdam, North Holland, 1105 AZ, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ, Netherlands
Ziekenhuis Rijnstate Arnhem
Gelderland, 6815 AD, Netherlands
American Heart of Poland S.A.
Chrzanów, Lesser Poland Voivodeship, 32-500, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-501, Poland
4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii
Wroclaw, Lower Silesian Voivodeship, 50-981, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warsaw, Masovian Voivodeship, 02-507, Poland
Instytut Kardiologii
Warsaw, Masovian Voivodeship, 04-628, Poland
American Heart of Poland S.A.
Kędzierzyn-Koźle, Opole Voivodeship, 47-200, Poland
American Heart of Poland S.A.
Mielec, Podkarpackie Voivodeship, 39-300, Poland
American Heart of Poland S.A.
Bielsko-Biala, Silesian Voivodeship, 43-316, Poland
American Heart of Poland S.A.
Dabrowa Górnicza, Silesian Voivodeship, 41-300, Poland
SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne
Katowice, Silesian Voivodeship, 40-635, Poland
American Heart of Poland S.A.
Tychy, Silesian Voivodeship, 43-100, Poland
American Heart of Poland S.A.
Ustroń, Silesian Voivodeship, 43-450, Poland
SPZOZ, Szpital Wojewódzki we Wloclawku
Kujawsko-pomorskie, 87-800, Poland
Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego
Poznan, 61-848, Poland
Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
Torun, 87-100, Poland
SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, 02-097, Poland
American Heart of Poland S.A.
Belchatów, Łódź Voivodeship, 97-400, Poland
Altai Regional Cardiological Dispensary
Barnaul, 656055, Russia
Regional Clinical Hospital №3
Chelyabinsk, 454021, Russia
Cardiological Dispensary
Ivanovo, 153012, Russia
Republic Clinical Hospital № 2
Kazan', 420043, Russia
Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, 650002, Russia
Medical Center "Alliance"
Kirovsk, Leningradskaya Region, 187342, Russia
Regional Clinical Hospital
Krasnoyarsk, 660022, Russia
National Research Center For Preventive Medicine
Moscow, 101990, Russia
City Clinical Hospital # 23 n.a."Medsantrud"
Moscow, 109240, Russia
City Clinical Hospital #15 named after O.M. Filatov
Moscow, 111539, Russia
University Clinical Hospital #1
Moscow, 119991, Russia
City Clinical Hospital n.a. S.P.Botkin
Moscow, 125284, Russia
City Clinical Hospital #5
Nizhny Novgorod, 603005, Russia
City Clinical Emergency Hospital # 2
Novosibirsk, 630008, Russia
Penza Regional Clinical Hospital n.a. N.N. Burdenko
Penza, 444026, Russia
Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov
Saint Petersburg, 197341, Russia
Scientific and Research Institution Of Cardiology
Tomsk, 634012, Russia
Volgograd Regional Clinical Cardiological Center
Volgograd, 400008, Russia
Ural Institute of Cardiology
Yekaterinburg, 620144, Russia
Hospital General Universitario de Alicante
Alicante, Alicante, 03010, Spain
Hospital Vall d´Hebrón
Barcelona, Barcelona, 08035, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital
Vigo, Pontevedra, 36214, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Uppsala University Hospital
Uppsala, Uppsala County, 75185, Sweden
Falu lasarett
Falun, 791 82, Sweden
Sahlgrenska Universitetsjukhuset
Gothenburg, 413 45, Sweden
Karlstad Central Hospital
Karlstad, 65185, Sweden
Universitetssjukhuset Örebro
Örebro, Örebro County, 701 85, Sweden
Royal Sussex County Hospital
Brighton, England, BN2 5BE, United Kingdom
The James Cook University Hospital
Middlesbrough, England, TS4 3BW, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN, United Kingdom
Ashford and Saint Peter's Hospital NHS Trust
Surrey, England, KT16 0PZ, United Kingdom
Saint Richards Hospital
West Sussex, England, PO19 6SE, United Kingdom
Royal Victoria Hospital
Northern Ireland, BT12 6BA, United Kingdom
Related Publications (4)
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.
PMID: 24268208BACKGROUNDWeisz 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.
PMID: 26474810RESULTAlexander 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.
PMID: 26555329RESULTFanaroff 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.
PMID: 30771861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Brian McNabb, MD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2011
First Posted
September 28, 2011
Study Start
October 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
July 15, 2016
Results First Posted
July 15, 2016
Record last verified: 2016-06