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

NCT ID: NCT01442038

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2651 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-02-28

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.

Conditions

Coronary Artery Disease; Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ranolazine

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Ranolazine

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

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Ranexa

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian McNabb, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Cardiology, PC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Heart Center Research, LLC

Huntsville, Alabama, United States

Scottsdale Healthcare

Scottsdale, Arizona, United States

Scottsdale Healthcare

Scottsdale, Arizona, United States

University of California San Diego

La Jolla, California, United States

Spectrum Clinical Research Institute, Inc

Moreno Valley, California, United States

Veterans Affairs San Diego Healthcare System

San Diego, California, United States

John Muir Medical Center Concord Campus

Walnut Creek, California, United States

South Denver Cardiology Associates, PC

Littleton, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Cardiology Associates of Fairfield County, PC

Stamford, Connecticut, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Zasa Clinical Research

Atlantis, Florida, United States

Cardiology Research Associates

Daytona Beach, Florida, United States

Broward General Medical Center

Fort Lauderdale, Florida, United States

University of Florida

Gainesville, Florida, United States

Michigan Heart, PC

Hialeah, Florida, United States

Jacksonville Heart Center

Jacksonville, Florida, United States

University of Florida Health Sciences Center-Jacksonville

Jacksonville, Florida, United States

East Coast Institute for Research

Jacksonville, Florida, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Florida Heart Institute

Orlando, Florida, United States

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

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

Tampa, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Gateway Cardiology, PC

Jerseyville, Illinois, United States

Indiana Heart Physicians, Inc.

Indianapolis, Indiana, United States

The Indiana Heart Hospital

Indianapolis, Indiana, United States

Northwest Indiana Cardiovascular Physicians

Valparaiso, Indiana, United States

Iowa Heart Center

West de Moines, Iowa, United States

Saint Joseph Cardiology Associates

Lexington, Kentucky, United States

Clinical Trials of America, Inc.

Minden, Louisiana, United States

Clinical Trials of America, Inc.

Shreveport, Louisiana, United States

Northeast Cardiology Associates

Bangor, Maine, United States

Baltimore Heart Associates

Baltimore, Maryland, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Saint Elizabeth's Medical Center

Boston, Massachusetts, United States

Cape Cod Research Institute

Hyannis, Massachusetts, United States

Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Essentia Health

Duluth, Minnesota, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Cardiology Associates of North Mississippi

Tupelo, Mississippi, United States

Saint John's Regional Medical Center

Springfield, Missouri, United States

Gateway Cardiology, PC

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

New York Methodist Hospital

Brooklyn, New York, United States

Buffalo Heart Group

Buffalo, New York, United States

SJH Cardiology Associates

Liverpool, New York, United States

Columbia University Medical Center

New York, New York, United States

Hudson Valley Heart Center

Poughkeepsie, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Central New York Cardiology

Utica, New York, United States

Westchester Medical Center

Valhalla, New York, United States

Buffalo Cardiology and Pulmonary Associates, PC

Williamsville, New York, United States

Asheville Cardiology Associates

Asheville, North Carolina, United States

Mid Carolina Cardiology

Charlotte, North Carolina, United States

Veterans Affairs Medical Center, Duke University Medical Center

Durham, North Carolina, United States

Carolina Cardiology Associates

High Point, North Carolina, United States

Wake Heart Research

Raleigh, North Carolina, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Cardiology Associates of Southeast Ohio, Inc.

Zanesville, Ohio, United States

Oklahoma City Veterans' Affairs Medical Center

Oklahoma City, Oklahoma, United States

South Oklahoma Heart Research

Oklahoma City, Oklahoma, United States

The Heart and Vascular Center

Beaver, Pennsylvania, United States

Central Bucks Cardiology

Doylestown, Pennsylvania, United States

Saint Vincent Health Care Center

Erie, Pennsylvania, United States

Veterans Administration Medical Center

Pittsburgh, Pennsylvania, United States

Pinnacle Health System

Wormleysburg, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Research Associates of Jackson

Jackson, Tennessee, United States

University of Tennessee

Knoxville, Tennessee, United States

Centennial Heart Cardiovascular Consultants, LLC

Nashville, Tennessee, United States

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

Dallas, Texas, United States

Humble Cardiology Associates

Humble, Texas, United States

Gamma Medical Research Inc.

Mission, Texas, United States

San Antonio Endovascular and Heart Institute

San Antonio, Texas, United States

Victoria Heart and Vascular Center

Victoria, Texas, United States

Utah Cardiology, PC

Layton, Utah, United States

University of Vermont Medical Center, Fletcher Allen Health Care

Burlington, Vermont, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

Landesklinikum Sankt Pölten

Sankt Pölten, Lower Austria, Austria

Landeskrankenhaus Graz West

Graz, Styria, Austria

Innsbruck Universitaetsklinik

Innsbruck, Tyrol, Austria

Allgemeines Krankenhaus der Stadt Linz

Linz, Upper Austria, Austria

Medizinische Universität Wien

Vienna, Vienna, Austria

Wilhelminenspital der Stadt Wien

Vienna, Vienna, Austria

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, Antwerpen, Belgium

Imelda Ziekenhuis

Bonheiden, Antwerpen, Belgium

Centre Hospitalier Universitaire Sart Tilman Liège

Liège, Liege, Belgium

ZOL Genk, Campus Saint Jan

Genk, Limburg, Belgium

Algemeen Ziekenhuis Sint-Jan

Bruges, West-Vlaanderen, Belgium

Royal Alexandra Hospital

Edmonton, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

New Brunswick Heart Centre

Saint John, New Brunswick, Canada

Hamilton Health Sciences, General Site

Hamilton, Ontario, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

Scarborough Cardiology Research Associates

Scarborough Village, Ontario, Canada

Saint Michael's Hospital

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Karlovarská krajská nemocnice a.s.

Karlovy Vary, Karlovarský kraj, Czechia

Krajská nemocnice Liberec a.s.

Liberec, Liberecký kraj, Czechia

Fakultní nemocnice Brno

Brno, , Czechia

Fakultní nemocnice u sv. Anny v Brne

Brno, , Czechia

Fakultní nemocnice Olomouc

Olomoucký Kraj, , Czechia

Fakultní nemocnice Královské Vinohrady

Prague, , Czechia

Všeobecná fakultní nemocnice v Praze

Prague, , Czechia

Fakultní Nemocnice v Motole

Prague, , Czechia

Centre Hospitalier d'Annecy

Pringy, Auvergne-Rhône-Alpes, France

Centre Hospitalier d'Arras

Arras, Hauts-de-France, France

Hôpital Rangueil

Toulouse, Midi-Pyrenees, France

Groupe hospitalier La Pitié Salpêtrière

Paris, , France

Hôpital Bichat-Claude Bernard

Paris, Île-de-France Region, France

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Kerckhoff-Klinik GmbH

Bad Nauheim, Hesse, Germany

Asklepios-Kliniken Langen

Langen, Hesse, Germany

Städtische Kliniken Bielefeld gGmbH

Bielefeld, North Rhine-Westphalia, Germany

Sankt Johannes Hospital

Dortmund, North Rhine-Westphalia, Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, North Rhine-Westphalia, Germany

Krankenhaus Der Barmherzigen Brüder Trier

Trier, Rhineland-Palatinate, Germany

Vivantes Klinikum im Friedrichshain

Berlin, State of Berlin, Germany

Kaplan Medical Center

Rehovot, Reheoboth, Israel

HaEmek Medical Center

Afula, , Israel

Barzilai Medical Center

Ashkelon, , Israel

Assaf Harofeh Medical Centre

Beer Yahkov, , Israel

Rambam Medical Center

Haifa, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Edith Wolfson Medical Center

Holon, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah Ein-Kerem Medical Centre

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Western Galilee Hospital

Nahariya, , Israel

Hillel Yaffe Medical Center

Ramat Gan, , Israel

Tel Aviv Souraski Medical Center

Tel Aviv, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

ZIV Medical Center

Zafed, , Israel

Ospedali Riuniti di Bergamo

Bergamo, Bergamo, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Firenze, Italy

Azienda Ospedaliera Universitaria San Martino

Genova, Genova, Italy

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

Milan, Milano, Italy

Ospedale Civile SS Annunziata ASL 1

Sassari, Sassari, Italy

Azienda Ospedaliera S. Sebastiano di Caserta

Caserta, , Italy

Azienda Ospedaliera "Maggiore della Carita" di Novara

Novara, , Italy

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

Palermo, , Italy

Azienda Ospedaliero Universitaria di Parma

Parma, , Italy

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

TweeSteden Ziekenhuis

Tilburg, North Brabant, Netherlands

Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Ziekenhuis Rijnstate Arnhem

Gelderland, , Netherlands

American Heart of Poland S.A.

Chrzanów, Lesser Poland Voivodeship, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii

Wroclaw, Lower Silesian Voivodeship, Poland

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

Warsaw, Masovian Voivodeship, Poland

Instytut Kardiologii

Warsaw, Masovian Voivodeship, Poland

American Heart of Poland S.A.

Kędzierzyn-Koźle, Opole Voivodeship, Poland

American Heart of Poland S.A.

Mielec, Podkarpackie Voivodeship, Poland

American Heart of Poland S.A.

Bielsko-Biala, Silesian Voivodeship, Poland

American Heart of Poland S.A.

Dabrowa Górnicza, Silesian Voivodeship, Poland

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

Katowice, Silesian Voivodeship, Poland

American Heart of Poland S.A.

Tychy, Silesian Voivodeship, Poland

American Heart of Poland S.A.

Ustroń, Silesian Voivodeship, Poland

SPZOZ, Szpital Wojewódzki we Wloclawku

Kujawsko-pomorskie, , Poland

Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego

Poznan, , Poland

Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu

Torun, , Poland

SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

Warsaw, , Poland

American Heart of Poland S.A.

Belchatów, Łódź Voivodeship, Poland

Altai Regional Cardiological Dispensary

Barnaul, , Russia

Regional Clinical Hospital №3

Chelyabinsk, , Russia

Cardiological Dispensary

Ivanovo, , Russia

Republic Clinical Hospital № 2

Kazan', , Russia

Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, , Russia

Medical Center "Alliance"

Kirovsk, Leningradskaya Region, , Russia

Regional Clinical Hospital

Krasnoyarsk, , Russia

National Research Center For Preventive Medicine

Moscow, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

University Clinical Hospital #1

Moscow, , Russia

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

Moscow, , Russia

City Clinical Hospital #5

Nizhny Novgorod, , Russia

City Clinical Emergency Hospital # 2

Novosibirsk, , Russia

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

Penza, , Russia

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

Saint Petersburg, , Russia

Scientific and Research Institution Of Cardiology

Tomsk, , Russia

Volgograd Regional Clinical Cardiological Center

Volgograd, , Russia

Ural Institute of Cardiology

Yekaterinburg, , Russia

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Hospital Vall d´Hebrón

Barcelona, Barcelona, Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital

Vigo, Pontevedra, Spain

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Clínico Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Uppsala University Hospital

Uppsala, Uppsala County, Sweden

Falu lasarett

Falun, , Sweden

Sahlgrenska Universitetsjukhuset

Gothenburg, , Sweden

Karlstad Central Hospital

Karlstad, , Sweden

Universitetssjukhuset Örebro

Örebro, Örebro County, Sweden

Royal Sussex County Hospital

Brighton, England, United Kingdom

The James Cook University Hospital

Middlesbrough, England, United Kingdom

Freeman Hospital

Newcastle upon Tyne, England, United Kingdom

Ashford and Saint Peter's Hospital NHS Trust

Surrey, England, United Kingdom

Saint Richards Hospital

West Sussex, England, United Kingdom

Royal Victoria Hospital

Northern Ireland, , United Kingdom

Countries

United States; Austria; Belgium; Canada; Czechia; France; Germany; Israel; Italy; Netherlands; Poland; Russia; Spain; Sweden; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 24268208 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26474810 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26555329 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30771861 (View on PubMed)

Other Identifiers

2011-002507-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-259-0116

Identifier Type: -

Identifier Source: org_study_id