Trial record 1 of 1 for:    River-PCI
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Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI) (RIVER-PCI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01442038
First received: September 22, 2011
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Angina Pectoris
Drug: Ranolazine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Time from randomization to first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomization to sudden cardiac death. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time from randomization to cardiovascular death. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time from randomization to MI. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 2600
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine 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.

Other Name: Ranexa
Placebo Comparator: Placebo 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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). 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442038

  Hide Study Locations
Locations
United States, Alabama
Cardiology, PC
Birmingham, Alabama, United States, 35211
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85251
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, California
University of California San Diego
La Jolla, California, United States, 92037
Spectrum Clinical Research Institute, Inc
Moreno Valley, California, United States, 92553
Veterans Affairs San Diego Healthcare System
San Diego, California, United States, 92161
John Muir Medical Center Concord Campus
Walnut Creek, California, United States, 94598
United States, Colorado
South Denver Cardiology Associates, PC
Littleton, Colorado, United States, 80120
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Cardiology Associates of Fairfield County, PC
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Zasa Clinical Research
Atlantis, Florida, United States, 33462
Cardiology Research Associates
Daytona Beach, Florida, United States, 32117
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
University of Florida
Gainesville, Florida, United States, 32610
Michigan Heart, PC
Hialeah, Florida, United States, 33010
Jacksonville Heart Center
Jacksonville, Florida, United States, 32207
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
University of Florida Health Sciences Center-Jacksonville
Jacksonville, Florida, United States, 32209
East Coast Institute for Research
Jacksonville, Florida, United States, 32216
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Heart Institute
Orlando, Florida, United States, 32803
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States, 32401
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
Tampa, Florida, United States, 33613
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Gateway Cardiology, PC
Jerseyville, Illinois, United States, 62052
United States, Indiana
Indiana Heart Physicians, Inc.
Indianapolis, Indiana, United States, 46237
The Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
Northwest Indiana Cardiovascular Physicians
Valparaiso, Indiana, United States, 46383
United States, Iowa
Iowa Heart Center
West De Moines, Iowa, United States, 50266
United States, Kentucky
Saint Joseph Cardiology Associates
Lexington, Kentucky, United States, 40504
United States, Louisiana
Clinical Trials of America, Inc.
Minden, Louisiana, United States, 71055
Clinical Trials of America, Inc.
Shreveport, Louisiana, United States, 71103
United States, Maine
Northeast Cardiology Associates
Bangor, Maine, United States, 04401
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Baltimore Heart Associates
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Saint Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Cape Cod Research Institute
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
United States, Mississippi
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States, 38801
United States, Missouri
Gateway Cardiology, PC
Saint Louis, Missouri, United States, 63128
Saint John's Regional Medical Center
Springfield, Missouri, United States, 65804
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Buffalo Heart Group
Buffalo, New York, United States, 14215
SJH Cardiology Associates
Liverpool, New York, United States, 13088
Columbia University Medical Center
New York, New York, United States, 10032
Hudson Valley Heart Center
Poughkeepsie, New York, United States, 12601
Stony Brook University Medical Center
Stony Brook, New York, United States, 11790
Central New York Cardiology
Utica, New York, United States, 13501
Westchester Medical Center
Valhalla, New York, United States, 10595
Buffalo Cardiology and Pulmonary Associates, PC
Williamsville, New York, United States, 14221
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
Mid Carolina Cardiology
Charlotte, North Carolina, United States, 28204
Veterans Affairs Medical Center, Duke University Medical Center
Durham, North Carolina, United States, 27705
Carolina Cardiology Associates
High Point, North Carolina, United States, 27262
Wake Heart Research
Raleigh, North Carolina, United States, 27610
United States, Ohio
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
Cardiology Associates of Southeast Ohio, Inc.
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Oklahoma City Veterans' Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States, 73135
United States, Pennsylvania
The Heart and Vascular Center
Beaver, Pennsylvania, United States, 15009
Central Bucks Cardiology
Doylestown, Pennsylvania, United States, 18901
Saint Vincent Health Care Center
Erie, Pennsylvania, United States, 16502
Veterans Administration Medical Center
Pittsburgh, Pennsylvania, United States, 15240
Pinnacle Health System
Wormleysburg, Pennsylvania, United States, 17043
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Research Associates of Jackson
Jackson, Tennessee, United States, 38301
University of Tennessee
Knoxville, Tennessee, United States, 37920
Centennial Heart Cardiovascular Consultants, LLC
Nashville, Tennessee, United States, 37203
United States, Texas
North Texas Healthcare System, Dept. of Veteran's Affairs
Dallas, Texas, United States, 75216
Humble Cardiology Associates
Humble, Texas, United States, 77338
Gamma Medical Research Inc.
Mission, Texas, United States, 78572
San Antonio Endovascular and Heart Institute
San Antonio, Texas, United States, 78258
Victoria Heart and Vascular Center
Victoria, Texas, United States, 77901
United States, Utah
Utah Cardiology, PC
Layton, Utah, United States, 84041
United States, Vermont
University of Vermont Medical Center, Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
Austria
Landesklinikum Sankt Pölten
Saint Pölten, Lower Austria, Austria, 3100
Landeskrankenhaus Graz West
Graz, Styria, Austria, 8020
Innsbruck Universitaetsklinik
Innsbruck, Tyrol, Austria, 6020
Allgemeines Krankenhaus der Stadt Linz
Linz, Upper Austria, Austria, 4020
Wilhelminenspital der Stadt Wien
Wien, Vienna, Austria, 1160
Medizinische Universität Wien
Wien, Vienna, Austria, 1090
Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, Antwerpen, Belgium, 2020
Imelda Ziekenhuis
Bonheiden, Antwerpen, Belgium, 2820
ZOL Genk, Campus Saint Jan
Genk, Limburg, Belgium, 3600
Algemeen Ziekenhuis Sint-Jan
Brugge, West-Vlaanderen, Belgium, 8000
Centre Hospitalier Universitaire Sart Tilman Liège
Liege, Belgium, 4000
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, New Brunswick
New Brunswick Heart Centre
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Hamilton Health Sciences, General Site
Hamilton, Ontario, Canada, L8L 2X2
Scarborough Cardiology Research Associates
Scarborough, Ontario, Canada, M1E 5E9
Saint Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2W 1T8
Montreal Heart Institute
Montréal, Quebec, Canada, H1T 1C8
Hôpital du Sacré-Coeur de Montréal
Montréal, Quebec, Canada, H4J 1C5
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec City, Quebec, Canada, G1V 4G5
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Czech Republic
Karlovarská krajská nemocnice a.s.
Karlovy Vary, Karlovarský kraj, Czech Republic, 360 66
Krajská nemocnice Liberec a.s.
Liberec, Liberecký kraj, Czech Republic, 460 63
Fakultní nemocnice Brno
Brno, Czech Republic, 625 00
Fakultní nemocnice u sv. Anny v Brne
Brno, Czech Republic, 656 91
Fakultní nemocnice Olomouc
Olomoucký kraj, Czech Republic, 775 20
Všeobecná fakultní nemocnice v Praze
Praha, Czech Republic, 128 08
Fakultní Nemocnice v Motole
Praha, Czech Republic, 150 06
Fakultní nemocnice Královské Vinohrady
Praha, Czech Republic, 100 34
France
Hôpital Bichat-Claude Bernard
Paris, Ile-de-France, France, 75018
Hôpital Rangueil
Toulouse Cedex 9, Midi-Pyrenees, France, 31059
Centre Hospitalier d'Arras
Arras, Nord Pas-De-Calais, France, 62022
Centre Hospitalier d'Annecy
Pringy, Rhone-Alpes, France, 74374
Groupe hospitalier La Pitié Salpêtrière
Paris, France, 75013
Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Kerckhoff-Klinik GmbH
Bad Nauheim, Hessen, Germany, 61231
Asklepios-Kliniken Langen
Langen, Hessen, Germany, 63225
Städtische Kliniken Bielefeld gGmbH
Bielefeld, Nordrhein-westfalen, Germany, 33604
Sankt Johannes Hospital
Dortmund, Nordrhein-westfalen, Germany, 44137
Kliniken Maria Hilf GmbH
Mönchengladbach, Nordrhein-westfalen, Germany, 41063
Krankenhaus Der Barmherzigen Brüder Trier
Trier, Rheinland-pfalz, Germany, 54292
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Israel
Kaplan Medical Center
Rehovot, Reheoboth, Israel, 76100
HaEmek Medical Center
Afula, Israel, 18101
Barzilai Medical Center
Ashkelon, Israel, 78287
Assaf Harofeh Medical Centre
Beer Yahkov, Israel, 70300
Bnai Zion Medical Center
Haifa, Israel, 33394
Rambam Medical Center
Haifa, Israel, 31096
Edith Wolfson Medical Center
Holon, Israel, 58100
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Hadassah Ein-Kerem Medical Centre
Jerusalem, Israel, 91120
Meir Medical Center
Kfar Saba, Israel, 44281
Western Galilee Hospital
Nahariya, Israel, 22100
Hillel Yaffe Medical Center
Ramat Gan, Israel
Tel Aviv Souraski Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621
ZIV Medical Center
Zafed, Israel, 13100
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Azienda Ospedaliera S. Sebastiano di Caserta
Caserta, Italy, 81100
Azienda Ospedaliero-Universitaria Careggi
Firenze, Italy, 50134
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele
Milano, Italy, 20132
Azienda Ospedaliera "Maggiore della Carita" di Novara
Novara, Italy, 28100
A.R.N.A.S. Civico G. Di Cristina Benfratelli
Palermo, Italy, 90127
Azienda Ospedaliero Universitaria di Parma
Parma, Italy, 43100
Ospedale Civile SS Annunziata ASL 1
Sassari, Italy, 07100
Netherlands
Catharina Ziekenhuis
Eindhoven, Noord-brabant, Netherlands, 5623 EJ
TweeSteden Ziekenhuis
Tilburg, Noord-brabant, Netherlands, 5042 AD
Academisch Medisch Centrum
Amsterdam, Noord-holland, Netherlands, 1105 AZ
Maasstad Ziekenhuis
Rotterdam, Zuid-holland, Netherlands, 3079 DZ
Ziekenhuis Rijnstate Arnhem
Gelderland, Netherlands, 6815 AD
Poland
4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii
Wroclaw, Dolnoslaskie, Poland, 50-981
American Heart of Poland S.A.
Belchatów, Lodzkie, Poland, 97-400
American Heart of Poland S.A.
Chrzanów, Malopolskie, Poland, 32-500
Szpital Uniwersytecki w Krakowie
Kraków, Malopolskie, Poland, 31-501
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warszawa, Mazowieckie, Poland, 02-507
Instytut Kardiologii
Warszawa, Mazowieckie, Poland, 04-628
American Heart of Poland S.A.
Kedzierzyn Kozle, Opolskie, Poland, 47-200
American Heart of Poland S.A.
Mielec, Podkarpackie, Poland, 39-300
American Heart of Poland S.A.
Bielsko-Biala, Slaskie, Poland, 43-316
American Heart of Poland S.A.
Dabrowa Górnicza, Slaskie, Poland, 41-300
SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne
Katowice, Slaskie, Poland, 40-635
American Heart of Poland S.A.
Tychy, Slaskie, Poland, 43-100
American Heart of Poland S.A.
Ustron, Slaskie, Poland, 43-450
SPZOZ, Szpital Wojewódzki we Wloclawku
Kujawsko-pomorskie, Poland, 87-800
Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego
Poznan, Poland, 61-848
Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
Torun, Poland, 87-100
SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warszawa, Poland, 02-097
Russian Federation
Altai Regional Cardiological Dispensary
Barnaul, Russian Federation, 656055
Regional Clinical Hospital №3
Chelyabinsk, Russian Federation, 454021
Ural Institute of Cardiology
Ekaterinburg, Russian Federation, 620144
Cardiological Dispensary
Ivanovo, Russian Federation, 153012
Republic Clinical Hospital № 2
Kazan, Russian Federation, 420043
Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, Russian Federation, 650002
Medical Center "Alliance"
Kirovsk, Leningradskaya Region, Russian Federation, 187342
Regional Clinical Hospital
Krasnoyarsk, Russian Federation, 660022
National Research Center For Preventive Medicine
Moscow, Russian Federation, 101990
City Clinical Hospital #15 named after O.M. Filatov
Moscow, Russian Federation, 111539
City Clinical Hospital n.a. S.P.Botkin
Moscow, Russian Federation, 125284
University Clinical Hospital #1
Moscow, Russian Federation, 119991
City Clinical Hospital # 23 n.a."Medsantrud"
Moscow, Russian Federation, 109240
City Clinical Hospital #5
Nizhni Novgorod, Russian Federation, 603005
City Clinical Emergency Hospital # 2
Novosibirsk, Russian Federation, 630008
Penza Regional Clinical Hospital n.a. N.N. Burdenko
Penza, Russian Federation, 444026
Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov
Saint-Petersburg, Russian Federation, 197341
Scientific and Research Institution Of Cardiology
Tomsk, Russian Federation, 634012
Volgograd Regional Clinical Cardiological Center
Volgograd, Russian Federation, 400008
Spain
Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Universitario de Bellvitge
L´Hospitalet de Llobregat, Barcelona, Spain, 08907
Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital
Vigo, Pontevedra, Spain, 36214
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Vall d´Hebrón
Barcelona, Spain, 08035
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Clínico Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sweden
Universitetssjukhuset Örebro
Örebro, Orebro, Sweden, 701 85
Falu lasarett
Falun, Sweden, 791 82
Sahlgrenska Universitetsjukhuset
Göteborg, Sweden, 413 45
Karlstad Central Hospital
Karlstad, Sweden, 65185
Uppsala University Hospital
Uppsala, Sweden, 75185
United Kingdom
Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
The James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Freeman Hospital
Newcastle Upon Tyne, England, United Kingdom, NE7 7DN
Ashford and Saint Peter's Hospital NHS Trust
Surrey, England, United Kingdom, KT16 0PZ
Saint Richards Hospital
West Sussex, England, United Kingdom, PO19 6SE
Royal Victoria Hospital
Northern Ireland, United Kingdom, BT12 6BA
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Ramin Farzaneh-Far, MD, FACC Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01442038     History of Changes
Other Study ID Numbers: GS-US-259-0116, 2011-002507-15
Study First Received: September 22, 2011
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Poland: The Central Register of Clinical Trials
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014