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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442038
• Other study ID #: GS-US-259-0116
• Secondary ID: 2011-002507-15
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2011
• Last updated: February 13, 2015
• Start date: October 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of HealthItaly: The Italian Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)Poland: Ethics CommitteeRussia: Ministry of Health of the Russian FederationPoland: The Central Register of Clinical TrialsSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySweden: Regional Ethical Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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-PCI on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2653
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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). Subjects may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as anytime 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 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. Subjects 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 subject post-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. Subjects randomized in-hospital on day of planned discharge or in clinic are considered stable. Subjects 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 subject 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. Subjects 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 subject has had a stress test post-PCI and prior to Randomization and no further intervention is planned, the subject may be enrolled within 14 days from the last PCI.

2. Unrevascularized left main coronary artery stenosis = 50%. Subjects 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 GFR < 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. Subjects 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. Subjects 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 subjects 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-CAD 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Graz West	Graz	Styria
Austria	Innsbruck Universitaetsklinik	Innsbruck	Tyrol
Austria	Allgemeines Krankenhaus der Stadt Linz	Linz	Upper Austria
Austria	Landesklinikum Sankt Pölten	Saint Pölten	Lower Austria
Austria	Medizinische Universität Wien	Wien	Vienna
Austria	Wilhelminenspital der Stadt Wien	Wien	Vienna
Belgium	Ziekenhuis Netwerk Antwerpen Middelheim	Antwerp	Antwerpen
Belgium	Imelda Ziekenhuis	Bonheiden	Antwerpen
Belgium	Algemeen Ziekenhuis Sint-Jan	Brugge	West-Vlaanderen
Belgium	ZOL Genk, Campus Saint Jan	Genk	Limburg
Belgium	Centre Hospitalier Universitaire Sart Tilman Liège	Liege
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Hamilton Health Sciences, General Site	Hamilton	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	Hôpital du Sacré-Coeur de Montréal	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec City	Quebec
Canada	New Brunswick Heart Centre	Saint John	New Brunswick
Canada	Scarborough Cardiology Research Associates	Scarborough	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Saint Michael's Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Czech Republic	Fakultní nemocnice Brno	Brno
Czech Republic	Fakultní nemocnice u sv. Anny v Brne	Brno
Czech Republic	Karlovarská krajská nemocnice a.s.	Karlovy Vary	Karlovarský kraj
Czech Republic	Krajská nemocnice Liberec a.s.	Liberec	Liberecký kraj
Czech Republic	Fakultní nemocnice Olomouc	Olomoucký kraj
Czech Republic	Fakultní nemocnice Královské Vinohrady	Praha
Czech Republic	Fakultní Nemocnice v Motole	Praha
Czech Republic	Všeobecná fakultní nemocnice v Praze	Praha
France	Centre Hospitalier d'Arras	Arras	Nord Pas-De-Calais
France	Groupe hospitalier La Pitié Salpêtrière	Paris
France	Hôpital Bichat-Claude Bernard	Paris	Ile-de-France
France	Centre Hospitalier d'Annecy	Pringy	Rhone-Alpes
France	Hôpital Rangueil	Toulouse Cedex 9	Midi-Pyrenees
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim	Hessen
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Städtische Kliniken Bielefeld gGmbH	Bielefeld	Nordrhein-westfalen
Germany	Sankt Johannes Hospital	Dortmund	Nordrhein-westfalen
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Wuerttemberg
Germany	Asklepios-Kliniken Langen	Langen	Hessen
Germany	Kliniken Maria Hilf GmbH	Mönchengladbach	Nordrhein-westfalen
Germany	Krankenhaus Der Barmherzigen Brüder Trier	Trier	Rheinland-pfalz
Israel	HaEmek Medical Center	Afula
Israel	Barzilai Medical Center	Ashkelon
Israel	Assaf Harofeh Medical Centre	Beer Yahkov
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Hadassah Ein-Kerem Medical Centre	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Western Galilee Hospital	Nahariya
Israel	Hillel Yaffe Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rehovot	Reheoboth
Israel	Tel Aviv Souraski Medical Center	Tel Aviv
Israel	Sheba Medical Center	Tel Hashomer
Israel	ZIV Medical Center	Zafed
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Azienda Ospedaliera S. Sebastiano di Caserta	Caserta
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Azienda Ospedaliera Universitaria San Martino	Genova
Italy	Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele	Milano
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	Ospedale Civile SS Annunziata ASL 1	Sassari
Netherlands	Academisch Medisch Centrum	Amsterdam	Noord-holland
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-brabant
Netherlands	Ziekenhuis Rijnstate Arnhem	Gelderland
Netherlands	Maasstad Ziekenhuis	Rotterdam	Zuid-holland
Netherlands	TweeSteden Ziekenhuis	Tilburg	Noord-brabant
Poland	American Heart of Poland S.A.	Belchatów	Lodzkie
Poland	American Heart of Poland S.A.	Bielsko-Biala	Slaskie
Poland	American Heart of Poland S.A.	Chrzanów	Malopolskie
Poland	American Heart of Poland S.A.	Dabrowa Górnicza	Slaskie
Poland	SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne	Katowice	Slaskie
Poland	American Heart of Poland S.A.	Kedzierzyn Kozle	Opolskie
Poland	Szpital Uniwersytecki w Krakowie	Kraków	Malopolskie
Poland	SPZOZ, Szpital Wojewódzki we Wloclawku	Kujawsko-pomorskie
Poland	American Heart of Poland S.A.	Mielec	Podkarpackie
Poland	Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego	Poznan
Poland	Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu	Torun
Poland	American Heart of Poland S.A.	Tychy	Slaskie
Poland	American Heart of Poland S.A.	Ustron	Slaskie
Poland	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie	Warszawa	Mazowieckie
Poland	Instytut Kardiologii	Warszawa	Mazowieckie
Poland	SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie	Warszawa
Poland	4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii	Wroclaw	Dolnoslaskie
Russian Federation	Altai Regional Cardiological Dispensary	Barnaul
Russian Federation	Regional Clinical Hospital ?3	Chelyabinsk
Russian Federation	Ural Institute of Cardiology	Ekaterinburg
Russian Federation	Cardiological Dispensary	Ivanovo
Russian Federation	Republic Clinical Hospital ? 2	Kazan
Russian Federation	Research Institute for Complex Issues of Cardiovascular Diseases	Kemerovo
Russian Federation	Medical Center "Alliance"	Kirovsk, Leningradskaya Region
Russian Federation	Regional Clinical Hospital	Krasnoyarsk
Russian Federation	City Clinical Hospital # 23 n.a."Medsantrud"	Moscow
Russian Federation	City Clinical Hospital #15 named after O.M. Filatov	Moscow
Russian Federation	City Clinical Hospital n.a. S.P.Botkin	Moscow
Russian Federation	National Research Center For Preventive Medicine	Moscow
Russian Federation	University Clinical Hospital #1	Moscow
Russian Federation	City Clinical Hospital #5	Nizhni Novgorod
Russian Federation	City Clinical Emergency Hospital # 2	Novosibirsk
Russian Federation	Penza Regional Clinical Hospital n.a. N.N. Burdenko	Penza
Russian Federation	Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov	Saint-Petersburg
Russian Federation	Scientific and Research Institution Of Cardiology	Tomsk
Russian Federation	Volgograd Regional Clinical Cardiological Center	Volgograd
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital Vall d´Hebrón	Barcelona
Spain	Hospital Universitario de Bellvitge	L´Hospitalet de Llobregat	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Clínico Universitario Virgen de la Victoria	Malaga
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital	Vigo	Pontevedra
Sweden	Falu lasarett	Falun
Sweden	Sahlgrenska Universitetsjukhuset	Göteborg
Sweden	Karlstad Central Hospital	Karlstad
Sweden	Universitetssjukhuset Örebro	Örebro	Orebro
Sweden	Uppsala University Hospital	Uppsala
United Kingdom	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	Royal Victoria Hospital	Northern Ireland
United Kingdom	Ashford and Saint Peter's Hospital NHS Trust	Surrey	England
United Kingdom	Saint Richards Hospital	West Sussex	England
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	Zasa Clinical Research	Atlantis	Florida
United States	Baltimore Heart Associates	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Northeast Cardiology Associates	Bangor	Maine
United States	The Heart and Vascular Center	Beaver	Pennsylvania
United States	Cardiology, PC	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Saint Elizabeth's Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	Buffalo Heart Group	Buffalo	New York
United States	University of Vermont Medical Center, Fletcher Allen Health Care	Burlington	Vermont
United States	Mid Carolina Cardiology	Charlotte	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Ohio Health Research Institute	Columbus	Ohio
United States	North Texas Healthcare System, Dept. of Veteran's Affairs	Dallas	Texas
United States	Cardiology Research Associates	Daytona Beach	Florida
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Central Bucks Cardiology	Doylestown	Pennsylvania
United States	Essentia Health	Duluth	Minnesota
United States	Veterans Affairs Medical Center, Duke University Medical Center	Durham	North Carolina
United States	Saint Vincent Health Care Center	Erie	Pennsylvania
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	Carolina Cardiology Associates	High Point	North Carolina
United States	Humble Cardiology Associates	Humble	Texas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Cape Cod Research Institute	Hyannis	Massachusetts
United States	Indiana Heart Physicians, Inc.	Indianapolis	Indiana
United States	The Indiana Heart Hospital	Indianapolis	Indiana
United States	Research Associates of Jackson	Jackson	Tennessee
United States	East Coast Institute for Research	Jacksonville	Florida
United States	Jacksonville Heart Center	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Florida Health Sciences Center-Jacksonville	Jacksonville	Florida
United States	Gateway Cardiology, PC	Jerseyville	Illinois
United States	University of Tennessee	Knoxville	Tennessee
United States	University of California San Diego	La Jolla	California
United States	Utah Cardiology, PC	Layton	Utah
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Saint Joseph Cardiology Associates	Lexington	Kentucky
United States	South Denver Cardiology Associates, PC	Littleton	Colorado
United States	SJH Cardiology Associates	Liverpool	New York
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Clinical Trials of America, Inc.	Minden	Louisiana
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Gamma Medical Research Inc.	Mission	Texas
United States	Spectrum Clinical Research Institute, Inc	Moreno Valley	California
United States	Centennial Heart Cardiovascular Consultants, LLC	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Oklahoma City Veterans' Affairs Medical Center	Oklahoma City	Oklahoma
United States	South Oklahoma Heart Research	Oklahoma City	Oklahoma
United States	Florida Heart Institute	Orlando	Florida
United States	Cardiovascular Institute of Northwest Florida	Panama City	Florida
United States	Veterans Administration Medical Center	Pittsburgh	Pennsylvania
United States	Hudson Valley Heart Center	Poughkeepsie	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Wake Heart Research	Raleigh	North Carolina
United States	Saint Cloud Hospital	Saint Cloud	Minnesota
United States	Gateway Cardiology, PC	Saint Louis	Missouri
United States	San Antonio Endovascular and Heart Institute	San Antonio	Texas
United States	Veterans Affairs San Diego Healthcare System	San Diego	California
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Clinical Trials of America, Inc.	Shreveport	Louisiana
United States	Saint John's Regional Medical Center	Springfield	Missouri
United States	Cardiology Associates of Fairfield County, PC	Stamford	Connecticut
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute	Tampa	Florida
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Cardiology Associates of North Mississippi	Tupelo	Mississippi
United States	Central New York Cardiology	Utica	New York
United States	Westchester Medical Center	Valhalla	New York
United States	Northwest Indiana Cardiovascular Physicians	Valparaiso	Indiana
United States	Victoria Heart and Vascular Center	Victoria	Texas
United States	John Muir Medical Center Concord Campus	Walnut Creek	California
United States	Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center	West De Moines	Iowa
United States	Buffalo Cardiology and Pulmonary Associates, PC	Williamsville	New York
United States	Pinnacle Health System	Wormleysburg	Pennsylvania
United States	Cardiology Associates of Southeast Ohio, Inc.	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from randomization to first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization		One year	No
Secondary	Time from randomization to sudden cardiac death		One year	No
Secondary	Time from randomization to cardiovascular death		One year	No
Secondary	Time from randomization to myocardial infarction		One year	No