AzTrials
AzTrials

Coronary Artery DiseasePhase 3RIVER-PCINCT01442038

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

A Phase 3 study testing Ranolazine in people with Coronary Artery Disease and Angina Pectoris, run by Gilead Sciences at 218 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Angina Pectoris
What is being tested?
Ranolazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,651 participants
Where
218 sitesin 15 countries
Study dates
Oct 2011to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
Show all 12Show fewer
  • 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:
  • 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.
  • 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.

Who cannot join

  • 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:
  • 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)
Show all 19Show fewer
  • 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

Trial locations and contacts

218 sites in 15 countries.

218 sites in 15 countries

United States86 sites

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Zasa Clinical Research

    Atlantis, Florida, 33462

  • Baltimore Heart Associates

    Baltimore, Maryland, 21215

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Northeast Cardiology Associates

    Bangor, Maine, 04401

  • The Heart and Vascular Center

    Beaver, Pennsylvania, 15009

  • Cardiology, PC

    Birmingham, Alabama, 35211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Saint Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Buffalo Heart Group

    Buffalo, New York, 14215

  • University of Vermont Medical Center, Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Mid Carolina Cardiology

    Charlotte, North Carolina, 28204

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • North Texas Healthcare System, Dept. of Veteran's Affairs

    Dallas, Texas, 75216

  • Cardiology Research Associates

    Daytona Beach, Florida, 32117

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Central Bucks Cardiology

    Doylestown, Pennsylvania, 18901

  • Essentia Health

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center, Duke University Medical Center

    Durham, North Carolina, 27705

  • Saint Vincent Health Care Center

    Erie, Pennsylvania, 16502

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • University of Florida

    Gainesville, Florida, 32610

  • Michigan Heart, PC

    Hialeah, Florida, 33010

  • Carolina Cardiology Associates

    High Point, North Carolina, 27262

  • Humble Cardiology Associates

    Humble, Texas, 77338

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • Indiana Heart Physicians, Inc.

    Indianapolis, Indiana, 46237

  • The Indiana Heart Hospital

    Indianapolis, Indiana, 46250

  • Research Associates of Jackson

    Jackson, Tennessee, 38301

  • Jacksonville Heart Center

    Jacksonville, Florida, 32207

  • University of Florida Health Sciences Center-Jacksonville

    Jacksonville, Florida, 32209

  • East Coast Institute for Research

    Jacksonville, Florida, 32216

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Gateway Cardiology, PC

    Jerseyville, Illinois, 62052

  • University of Tennessee

    Knoxville, Tennessee, 37920

  • University of California San Diego

    La Jolla, California, 92037

  • Utah Cardiology, PC

    Layton, Utah, 84041

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Saint Joseph Cardiology Associates

    Lexington, Kentucky, 40504

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Clinical Trials of America, Inc.

    Minden, Louisiana, 71055

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Gamma Medical Research Inc.

    Mission, Texas, 78572

  • Spectrum Clinical Research Institute, Inc

    Moreno Valley, California, 92553

  • Centennial Heart Cardiovascular Consultants, LLC

    Nashville, Tennessee, 37203

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Oklahoma City Veterans' Affairs Medical Center

    Oklahoma City, Oklahoma, 73104

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma, 73135

  • Florida Heart Institute

    Orlando, Florida, 32803

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32401

  • Veterans Administration Medical Center

    Pittsburgh, Pennsylvania, 15240

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Wake Heart Research

    Raleigh, North Carolina, 27610

  • Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • San Antonio Endovascular and Heart Institute

    San Antonio, Texas, 78258

  • Veterans Affairs San Diego Healthcare System

    San Diego, California, 92161

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85251

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85258

  • Clinical Trials of America, Inc.

    Shreveport, Louisiana, 71103

  • Saint John's Regional Medical Center

    Springfield, Missouri, 65804

  • Gateway Cardiology, PC

    St Louis, Missouri, 63128

  • Cardiology Associates of Fairfield County, PC

    Stamford, Connecticut, 06905

  • Stony Brook University Medical Center

    Stony Brook, New York, 11790

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute

    Tampa, Florida, 33613

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801

  • Central New York Cardiology

    Utica, New York, 13501

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Northwest Indiana Cardiovascular Physicians

    Valparaiso, Indiana, 46383

  • Victoria Heart and Vascular Center

    Victoria, Texas, 77901

  • John Muir Medical Center Concord Campus

    Walnut Creek, California, 94598

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Iowa Heart Center

    West de Moines, Iowa, 50266

  • Buffalo Cardiology and Pulmonary Associates, PC

    Williamsville, New York, 14221

  • Pinnacle Health System

    Wormleysburg, Pennsylvania, 17043

  • Cardiology Associates of Southeast Ohio, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

Russia19 sites

  • Altai Regional Cardiological Dispensary

    Barnaul, 656055

  • Regional Clinical Hospital №3

    Chelyabinsk, 454021

  • Cardiological Dispensary

    Ivanovo, 153012

  • Republic Clinical Hospital № 2

    Kazan', 420043

  • Research Institute for Complex Issues of Cardiovascular Diseases

    Kemerovo, 650002

  • Medical Center "Alliance"

    Kirovsk, Leningradskaya Region, 187342

  • Regional Clinical Hospital

    Krasnoyarsk, 660022

  • National Research Center For Preventive Medicine

    Moscow, 101990

  • City Clinical Hospital # 23 n.a."Medsantrud"

    Moscow, 109240

  • City Clinical Hospital #15 named after O.M. Filatov

    Moscow, 111539

  • University Clinical Hospital #1

    Moscow, 119991

  • City Clinical Hospital n.a. S.P.Botkin

    Moscow, 125284

  • City Clinical Hospital #5

    Nizhny Novgorod, 603005

  • City Clinical Emergency Hospital # 2

    Novosibirsk, 630008

  • Penza Regional Clinical Hospital n.a. N.N. Burdenko

    Penza, 444026

  • Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov

    Saint Petersburg, 197341

  • Scientific and Research Institution Of Cardiology

    Tomsk, 634012

  • Volgograd Regional Clinical Cardiological Center

    Volgograd, 400008

  • Ural Institute of Cardiology

    Yekaterinburg, 620144

Other trials in Russia

Poland17 sites

  • American Heart of Poland S.A.

    Belchatów, Łódź Voivodeship, 97-400

  • American Heart of Poland S.A.

    Bielsko-Biala, Silesian Voivodeship, 43-316

  • American Heart of Poland S.A.

    Chrzanów, Lesser Poland Voivodeship, 32-500

  • American Heart of Poland S.A.

    Dabrowa Górnicza, Silesian Voivodeship, 41-300

  • SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne

    Katowice, Silesian Voivodeship, 40-635

  • American Heart of Poland S.A.

    Kędzierzyn-Koźle, Opole Voivodeship, 47-200

  • Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-501

  • SPZOZ, Szpital Wojewódzki we Wloclawku

    Kujawsko-pomorskie, 87-800

  • American Heart of Poland S.A.

    Mielec, Podkarpackie Voivodeship, 39-300

  • Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego

    Poznan, 61-848

  • Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu

    Torun, 87-100

  • American Heart of Poland S.A.

    Tychy, Silesian Voivodeship, 43-100

  • American Heart of Poland S.A.

    Ustroń, Silesian Voivodeship, 43-450

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

    Warsaw, Masovian Voivodeship, 02-507

  • Instytut Kardiologii

    Warsaw, Masovian Voivodeship, 04-628

  • SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

    Warsaw, 02-097

  • 4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii

    Wroclaw, Lower Silesian Voivodeship, 50-981

Other trials in Poland

Israel15 sites

  • HaEmek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78287

  • Assaf Harofeh Medical Centre

    Beer Yahkov, 70300

  • Rambam Medical Center

    Haifa, 31096

  • Bnai Zion Medical Center

    Haifa, 33394

  • Edith Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Ein-Kerem Medical Centre

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Western Galilee Hospital

    Nahariya, 22100

  • Hillel Yaffe Medical Center

    Ramat Gan

  • Kaplan Medical Center

    Rehovot, Reheoboth, 76100

  • Tel Aviv Souraski Medical Center

    Tel Aviv, 64239

  • Sheba Medical Center

    Tel HaShomer, 52621

  • ZIV Medical Center

    Zafed, 13100

Other trials in Israel

Canada13 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Hamilton Health Sciences, General Site

    Hamilton, Ontario, L8L 2X2

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2W 1T8

  • Hôpital du Sacré-Coeur de Montréal

    Montreal, Quebec, H4J 1C5

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec, G1V 4G5

  • New Brunswick Heart Centre

    Saint John, New Brunswick, E2L 4L2

  • Scarborough Cardiology Research Associates

    Scarborough Village, Ontario, M1E 5E9

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Saint Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Spain11 sites

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

  • Hospital Vall d´Hebrón

    Barcelona, Barcelona, 08035

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital

    Vigo, Pontevedra, 36214

Other trials in Spain

Italy9 sites

  • Ospedali Riuniti di Bergamo

    Bergamo, Bergamo, 24128

  • Azienda Ospedaliera S. Sebastiano di Caserta

    Caserta, 81100

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Firenze, 50134

  • Azienda Ospedaliera Universitaria San Martino

    Genova, Genova, 16132

  • Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele

    Milan, Milano, 20132

  • Azienda Ospedaliera "Maggiore della Carita" di Novara

    Novara, 28100

  • A.R.N.A.S. Civico G. Di Cristina Benfratelli

    Palermo, 90127

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43100

  • Ospedale Civile SS Annunziata ASL 1

    Sassari, Sassari, 07100

Other trials in Italy

Czechia8 sites

  • Fakultní nemocnice Brno

    Brno, 625 00

  • Fakultní nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Karlovarská krajská nemocnice a.s.

    Karlovy Vary, Carlsbad Region, 360 66

  • Krajská nemocnice Liberec a.s.

    Liberec, Liberec Region, 460 63

  • Fakultní nemocnice Olomouc

    Olomoucký Kraj, 775 20

  • Fakultní nemocnice Královské Vinohrady

    Prague, 100 34

  • Všeobecná fakultní nemocnice v Praze

    Prague, 128 08

  • Fakultní Nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Germany8 sites

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, Hesse, 61231

  • Vivantes Klinikum im Friedrichshain

    Berlin, State of Berlin, 10249

  • Städtische Kliniken Bielefeld gGmbH

    Bielefeld, North Rhine-Westphalia, 33604

  • Sankt Johannes Hospital

    Dortmund, North Rhine-Westphalia, 44137

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Asklepios-Kliniken Langen

    Langen, Hesse, 63225

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Krankenhaus Der Barmherzigen Brüder Trier

    Trier, Rhineland-Palatinate, 54292

Other trials in Germany

Austria6 sites

  • Landeskrankenhaus Graz West

    Graz, Styria, 8020

  • Innsbruck Universitaetsklinik

    Innsbruck, Tyrol, 6020

  • Allgemeines Krankenhaus der Stadt Linz

    Linz, Upper Austria, 4020

  • Landesklinikum Sankt Pölten

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

  • Wilhelminenspital der Stadt Wien

    Vienna, State of Vienna, 1160

Other trials in Austria

United Kingdom6 sites

  • Royal Sussex County Hospital

    Brighton, England, BN2 5BE

  • The James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Freeman Hospital

    Newcastle upon Tyne, England, NE7 7DN

  • Royal Victoria Hospital

    Northern Ireland, BT12 6BA

  • Ashford and Saint Peter's Hospital NHS Trust

    Surrey, England, KT16 0PZ

  • Saint Richards Hospital

    West Sussex, England, PO19 6SE

Other trials in United Kingdom

Belgium5 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, Antwerpen, 2020

  • Imelda Ziekenhuis

    Bonheiden, Antwerpen, 2820

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, West-Vlaanderen, 8000

  • ZOL Genk, Campus Saint Jan

    Genk, Limburg, 3600

  • Centre Hospitalier Universitaire Sart Tilman Liège

    Liège, Liege, 4000

Other trials in Belgium

France5 sites

  • Centre Hospitalier d'Arras

    Arras, Hauts-de-France, 62022

  • Groupe hospitalier La Pitié Salpêtrière

    Paris, 75013

  • Hôpital Bichat-Claude Bernard

    Paris, Île-de-France Region, 75018

  • Centre Hospitalier d'Annecy

    Pringy, Auvergne-Rhône-Alpes, 74374

  • Hôpital Rangueil

    Toulouse, Midi-Pyrenees, 31059

Other trials in France

Netherlands5 sites

  • Academisch Medisch Centrum

    Amsterdam, North Holland, 1105 AZ

  • Catharina Ziekenhuis

    Eindhoven, North Brabant, 5623 EJ

  • Ziekenhuis Rijnstate Arnhem

    Gelderland, 6815 AD

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, 3079 DZ

  • TweeSteden Ziekenhuis

    Tilburg, North Brabant, 5042 AD

Other trials in Netherlands

Sweden5 sites

  • Falu lasarett

    Falun, 791 82

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 45

  • Karlstad Central Hospital

    Karlstad, 65185

  • Universitetssjukhuset Örebro

    Örebro, Örebro County, 701 85

  • Uppsala University Hospital

    Uppsala, Uppsala County, 75185

Other trials in Sweden

About this study

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

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.

Being tested
Ranolazine, Placebo
Medical subject headings
Coronary Artery Disease, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanolazineDrug

    Also called Ranexa

    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.

  • PlaceboDrug

    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.

Study groups in NCT01442038
Study groupRoleWhat they receive
RanolazineExperimentalNot described
Receives: Drug: Ranolazine
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline through end of study (average 90 weeks)

Secondary outcomes (3)

  1. 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.

    Measured: Baseline through end of study (average 90 weeks)

  2. 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.

    Measured: Baseline through end of study (average 90 weeks)

  3. 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.

    Measured: Baseline through end of study (average 90 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,651 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442038
Sponsor's protocol ID
GS-US-259-0116
Other IDs
2011-002507-15
Acronym
RIVER-PCI
Status last verified
Jun 2016
First submitted
22 Sep 2011
Last updated
15 Jul 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24268208

  • 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.

    PubMed 26474810

  • 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.

    PubMed 26555329

  • 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.

    PubMed 30771861

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranolazine in people with Coronary Artery Disease and Angina Pectoris, run by Gilead Sciences at 218 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 218 sites in United States, Russia, Poland, Israel, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization (time frame: Baseline through end of study (average 90 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442038, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in