- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00391872
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome (PLATO)
10 februari 2012 bijgewerkt door: AstraZeneca
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
Ticagrelor is a new, reversible binding, anti-platelet medication.
Anti-platelet medications work to prevent the formation of blood clots.
Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS).
ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack.
ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle.
Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
18624
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
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Buenos Aires, Argentinië
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Santa Fe, Argentinië
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Kiev, Oekraïne
- Research Site
-
Makiyivka, Oekraïne
- Research Site
-
-
-
-
-
Feldkirch, Oostenrijk
- Research Site
-
Freistadt, Oostenrijk
- Research Site
-
Graz, Oostenrijk
- Research Site
-
Innsbruck, Oostenrijk
- Research Site
-
Linz, Oostenrijk
- Research Site
-
Modling, Oostenrijk
- Research Site
-
Villach, Oostenrijk
- Research Site
-
Wien, Oostenrijk
- Research Site
-
-
-
-
-
Bialystok, Polen
- Research Site
-
Bielsko-biala, Polen
- Research Site
-
Bydgoszcz, Polen
- Research Site
-
Bytom, Polen
- Research Site
-
Czestochowa, Polen
- Research Site
-
Elblag, Polen
- Research Site
-
Gda?sk, Polen
- Research Site
-
Gdynia, Polen
- Research Site
-
Grodzisk Mazowiecki, Polen
- Research Site
-
Inowroclaw, Polen
- Research Site
-
Katowice, Polen
- Research Site
-
Krakow, Polen
- Research Site
-
Lodz, Polen
- Research Site
-
Lublin, Polen
- Research Site
-
Olawa, Polen
- Research Site
-
Olsztyn, Polen
- Research Site
-
Opole, Polen
- Research Site
-
Ostrowiec Swietokrzyski, Polen
- Research Site
-
Plock, Polen
- Research Site
-
Poznan, Polen
- Research Site
-
Radom, Polen
- Research Site
-
Szczecin, Polen
- Research Site
-
Tarnow, Polen
- Research Site
-
Torun, Polen
- Research Site
-
Walbrzych, Polen
- Research Site
-
Warszawa, Polen
- Research Site
-
Wejherowo, Polen
- Research Site
-
Wloclawek, Polen
- Research Site
-
Wroclaw, Polen
- Research Site
-
Zamosc, Polen
- Research Site
-
-
-
-
-
Amadora, Portugal
- Research Site
-
Aveiro, Portugal
- Research Site
-
Braga, Portugal
- Research Site
-
Coimbra, Portugal
- Research Site
-
Leiria, Portugal
- Research Site
-
Lisboa, Portugal
- Research Site
-
Penafiel, Portugal
- Research Site
-
Santa Maria Da Feira, Portugal
- Research Site
-
Santarem, Portugal
- Research Site
-
Setubal, Portugal
- Research Site
-
Vila Nova de Gaia, Portugal
- Research Site
-
Vila Real, Portugal
- Research Site
-
-
-
-
-
San Juan, Puerto Rico
- Research Site
-
-
-
-
-
Braila, Roemenië
- Research Site
-
Brasov, Roemenië
- Research Site
-
Bucharest, Roemenië
- Research Site
-
Buzau, Roemenië
- Research Site
-
Craiova, Roemenië
- Research Site
-
Iasi, Roemenië
- Research Site
-
Suceava, Roemenië
- Research Site
-
-
Arges
-
Pitesti, Arges, Roemenië
- Research Site
-
-
Cluj
-
Cluj Napoca, Cluj, Roemenië
- Research Site
-
-
-
-
-
Barnaul, Russische Federatie
- Research Site
-
Ekaterinburg, Russische Federatie
- Research Site
-
Irkutsk, Russische Federatie
- Research Site
-
Kaliningrad, Russische Federatie
- Research Site
-
Kazan, Russische Federatie
- Research Site
-
Kemerovo, Russische Federatie
- Research Site
-
Krasnodar, Russische Federatie
- Research Site
-
Krasnoyarsk, Russische Federatie
- Research Site
-
Moscow, Russische Federatie
- Research Site
-
Murmansk, Russische Federatie
- Research Site
-
Nizhniy Novgorod, Russische Federatie
- Research Site
-
Novosibirsk, Russische Federatie
- Research Site
-
Rostov-na-donu, Russische Federatie
- Research Site
-
Samara, Russische Federatie
- Research Site
-
St. Petersburg, Russische Federatie
- Research Site
-
Tomsk, Russische Federatie
- Research Site
-
Tyumen, Russische Federatie
- Research Site
-
Vladivostok, Russische Federatie
- Research Site
-
-
Khanty-mansiysk Autonomous Dis
-
Khanty-mansiysk, Khanty-mansiysk Autonomous Dis, Russische Federatie
- Research Site
-
-
-
-
-
Singapore, Singapore
- Research Site
-
-
-
-
-
Bratislava, Slowakije
- Research Site
-
Kosice, Slowakije
- Research Site
-
Liptovsky Mikulas, Slowakije
- Research Site
-
Martin, Slowakije
- Research Site
-
Nitra, Slowakije
- Research Site
-
Nove Zamky, Slowakije
- Research Site
-
Piestany, Slowakije
- Research Site
-
Ruzomberok, Slowakije
- Research Site
-
Trnava, Slowakije
- Research Site
-
Zilina, Slowakije
- Research Site
-
-
-
-
Andalucia
-
Malaga, Andalucia, Spanje
- Research Site
-
Sevilla, Andalucia, Spanje
- Research Site
-
-
Asturias
-
Gijon, Asturias, Spanje
- Research Site
-
-
Cataluna
-
Barcelona, Cataluna, Spanje
- Research Site
-
Lerida, Cataluna, Spanje
- Research Site
-
Terrassa, Cataluna, Spanje
- Research Site
-
-
Comunidad Valenciana
-
Valencia, Comunidad Valenciana, Spanje
- Research Site
-
-
Comunidad de Madrid
-
Madrid, Comunidad de Madrid, Spanje
- Research Site
-
-
Extremadura
-
Caceres, Extremadura, Spanje
- Research Site
-
-
Galicia
-
Vigo(pontevedra), Galicia, Spanje
- Research Site
-
-
Islas Baleares
-
Palma de Mallorca, Islas Baleares, Spanje
- Research Site
-
-
-
-
-
Taipei, Taiwan
- Research Site
-
-
Kaohsiung
-
Niao-song-shiang, Kaohsiung, Taiwan
- Research Site
-
-
Taoyuan Hsien
-
Kweishan Shiang, Taoyuan Hsien, Taiwan
- Research Site
-
-
-
-
-
Bangkok, Thailand
- Research Site
-
Chiang Mai, Thailand
- Research Site
-
Khon Kaen, Thailand
- Research Site
-
-
-
-
-
Hradec Kralove, Tsjechische Republiek
- Research Site
-
Jihlava, Tsjechische Republiek
- Research Site
-
Kladno, Tsjechische Republiek
- Research Site
-
Liberec, Tsjechische Republiek
- Research Site
-
Olomouc, Tsjechische Republiek
- Research Site
-
Ostrava-poruba, Tsjechische Republiek
- Research Site
-
Pardubice, Tsjechische Republiek
- Research Site
-
Praha, Tsjechische Republiek
- Research Site
-
Slany, Tsjechische Republiek
- Research Site
-
Teplice, Tsjechische Republiek
- Research Site
-
Usti Nad Labem, Tsjechische Republiek
- Research Site
-
Usti Nad Orlici, Tsjechische Republiek
- Research Site
-
Zlin, Tsjechische Republiek
- Research Site
-
Znojmo, Tsjechische Republiek
- Research Site
-
-
CZ
-
Brno, CZ, Tsjechische Republiek
- Research Site
-
-
-
-
-
Basingstoke, Verenigd Koninkrijk
- Research Site
-
Birmingham, Verenigd Koninkrijk
- Research Site
-
Blackpool, Verenigd Koninkrijk
- Research Site
-
Dundee, Verenigd Koninkrijk
- Research Site
-
Edinburgh, Verenigd Koninkrijk
- Research Site
-
Glasgow, Verenigd Koninkrijk
- Research Site
-
Leicester, Verenigd Koninkrijk
- Research Site
-
London, Verenigd Koninkrijk
- Research Site
-
Manchester, Verenigd Koninkrijk
- Research Site
-
Middlesborough, Verenigd Koninkrijk
- Research Site
-
Poole, Verenigd Koninkrijk
- Research Site
-
Sheffield, Verenigd Koninkrijk
- Research Site
-
Swansea, Verenigd Koninkrijk
- Research Site
-
-
Lanarkshire
-
Airdrie, Lanarkshire, Verenigd Koninkrijk
- Research Site
-
-
Northern Ireland
-
Belfast, Northern Ireland, Verenigd Koninkrijk
- Research Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Verenigde Staten
- Research Site
-
Huntsville, Alabama, Verenigde Staten
- Research Site
-
Mobile, Alabama, Verenigde Staten
- Research Site
-
-
Arizona
-
Tucson, Arizona, Verenigde Staten
- Research Site
-
-
California
-
Bakersfield, California, Verenigde Staten
- Research Site
-
Beverly Hills, California, Verenigde Staten
- Research Site
-
Burbank, California, Verenigde Staten
- Research Site
-
Healdsburg, California, Verenigde Staten
- Research Site
-
Los Angeles, California, Verenigde Staten
- Research Site
-
Roseville, California, Verenigde Staten
- Research Site
-
Sacramento, California, Verenigde Staten
- Research Site
-
San Diego, California, Verenigde Staten
- Research Site
-
Torrance, California, Verenigde Staten
- Research Site
-
-
Colorado
-
Fort Collins, Colorado, Verenigde Staten
- Research Site
-
-
Connecticut
-
Danbury, Connecticut, Verenigde Staten
- Research Site
-
Hartford, Connecticut, Verenigde Staten
- Research Site
-
-
Delaware
-
Newark, Delaware, Verenigde Staten
- Research Site
-
-
District of Columbia
-
Washington, District of Columbia, Verenigde Staten
- Research Site
-
-
Florida
-
Atlantis, Florida, Verenigde Staten
- Research Site
-
Daytona Beach, Florida, Verenigde Staten
- Research Site
-
Ft. Lauderdale, Florida, Verenigde Staten
- Research Site
-
Hollywood, Florida, Verenigde Staten
- Research Site
-
Jacksonville, Florida, Verenigde Staten
- Research Site
-
Jupiter, Florida, Verenigde Staten
- Research Site
-
Melbourne, Florida, Verenigde Staten
- Research Site
-
Miami Beach, Florida, Verenigde Staten
- Research Site
-
Ocala, Florida, Verenigde Staten
- Research Site
-
Orlando, Florida, Verenigde Staten
- Research Site
-
Ormond Beach, Florida, Verenigde Staten
- Research Site
-
Pensacola, Florida, Verenigde Staten
- Research Site
-
Sarasota, Florida, Verenigde Staten
- Research Site
-
St Petersburg, Florida, Verenigde Staten
- Research Site
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten
- Research Site
-
Park Ridge, Illinois, Verenigde Staten
- Research Site
-
Rock Island, Illinois, Verenigde Staten
- Research Site
-
Rockford, Illinois, Verenigde Staten
- Research Site
-
-
Indiana
-
Indianapolis, Indiana, Verenigde Staten
- Research Site
-
Muncie, Indiana, Verenigde Staten
- Research Site
-
Valparaiso, Indiana, Verenigde Staten
- Research Site
-
-
Iowa
-
Iowa City, Iowa, Verenigde Staten
- Research Site
-
West Des Moines, Iowa, Verenigde Staten
- Research Site
-
-
Kansas
-
Kansas City, Kansas, Verenigde Staten
- Research Site
-
Olathe, Kansas, Verenigde Staten
- Research Site
-
-
Kentucky
-
Ashland, Kentucky, Verenigde Staten
- Research Site
-
Louisville, Kentucky, Verenigde Staten
- Research Site
-
-
Louisiana
-
Shreveport, Louisiana, Verenigde Staten
- Research Site
-
-
Maine
-
Auburn, Maine, Verenigde Staten
- Research Site
-
Bangor, Maine, Verenigde Staten
- Research Site
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten
- Research Site
-
Bethesda, Maryland, Verenigde Staten
- Research Site
-
Salisbury, Maryland, Verenigde Staten
- Research Site
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten
- Research Site
-
Springfield, Massachusetts, Verenigde Staten
- Research Site
-
-
Michigan
-
Ann Arbor, Michigan, Verenigde Staten
- Research Site
-
Kalamazoo, Michigan, Verenigde Staten
- Research Site
-
Lansing, Michigan, Verenigde Staten
- Research Site
-
Laper, Michigan, Verenigde Staten
- Research Site
-
Pontiac, Michigan, Verenigde Staten
- Research Site
-
Royal Oak, Michigan, Verenigde Staten
- Research Site
-
Saginaw, Michigan, Verenigde Staten
- Research Site
-
Troy, Michigan, Verenigde Staten
- Research Site
-
Ypsilanti, Michigan, Verenigde Staten
- Research Site
-
-
Minnesota
-
Duluth, Minnesota, Verenigde Staten
- Research Site
-
Minneapolis, Minnesota, Verenigde Staten
- Research Site
-
St Paul, Minnesota, Verenigde Staten
- Research Site
-
-
Mississippi
-
Tupelo, Mississippi, Verenigde Staten
- Research Site
-
-
Missouri
-
Columbia, Missouri, Verenigde Staten
- Research Site
-
Joplin, Missouri, Verenigde Staten
- Research Site
-
Kansas City, Missouri, Verenigde Staten
- Research Site
-
St Louis, Missouri, Verenigde Staten
- Research Site
-
-
Nebraska
-
Lincoln, Nebraska, Verenigde Staten
- Research Site
-
Omaha, Nebraska, Verenigde Staten
- Research Site
-
Papillion, Nebraska, Verenigde Staten
- Research Site
-
-
New Jersey
-
Newark, New Jersey, Verenigde Staten
- Research Site
-
Oakland, New Jersey, Verenigde Staten
- Research Site
-
Paterson, New Jersey, Verenigde Staten
- Research Site
-
-
New Mexico
-
Albuquerque, New Mexico, Verenigde Staten
- Research Site
-
-
New York
-
Brooklyn, New York, Verenigde Staten
- Research Site
-
Buffalo, New York, Verenigde Staten
- Research Site
-
Johnson City, New York, Verenigde Staten
- Research Site
-
Kingston, New York, Verenigde Staten
- Research Site
-
New Hartford, New York, Verenigde Staten
- Research Site
-
New York, New York, Verenigde Staten
- Research Site
-
Rochester, New York, Verenigde Staten
- Research Site
-
Syracuse, New York, Verenigde Staten
- Research Site
-
Williamsville, New York, Verenigde Staten
- Research Site
-
-
North Carolina
-
Chapel Hill, North Carolina, Verenigde Staten
- Research Site
-
Charlotte, North Carolina, Verenigde Staten
- Research Site
-
Greensboro, North Carolina, Verenigde Staten
- Research Site
-
High Point, North Carolina, Verenigde Staten
- Research Site
-
Raleigh, North Carolina, Verenigde Staten
- Research Site
-
Winston-salem, North Carolina, Verenigde Staten
- Research Site
-
-
Ohio
-
Cleveland, Ohio, Verenigde Staten
- Research Site
-
Columbus, Ohio, Verenigde Staten
- Research Site
-
Kettering, Ohio, Verenigde Staten
- Research Site
-
Zanesville, Ohio, Verenigde Staten
- Research Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Verenigde Staten
- Research Site
-
Tulsa, Oklahoma, Verenigde Staten
- Research Site
-
-
Oregon
-
Bend, Oregon, Verenigde Staten
- Research Site
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, Verenigde Staten
- Research Site
-
Danville, Pennsylvania, Verenigde Staten
- Research Site
-
Doylestown, Pennsylvania, Verenigde Staten
- Research Site
-
Harrisburg, Pennsylvania, Verenigde Staten
- Research Site
-
Lancaster, Pennsylvania, Verenigde Staten
- Research Site
-
Langhorne, Pennsylvania, Verenigde Staten
- Research Site
-
Philadelphia, Pennsylvania, Verenigde Staten
- Research Site
-
Pittsburgh, Pennsylvania, Verenigde Staten
- Research Site
-
Sayre, Pennsylvania, Verenigde Staten
- Research Site
-
Sellersville, Pennsylvania, Verenigde Staten
- Research Site
-
Wormleysburg, Pennsylvania, Verenigde Staten
- Research Site
-
York, Pennsylvania, Verenigde Staten
- Research Site
-
-
Rhode Island
-
Providence, Rhode Island, Verenigde Staten
- Research Site
-
Wakefield, Rhode Island, Verenigde Staten
- Research Site
-
-
South Carolina
-
Anderson, South Carolina, Verenigde Staten
- Research Site
-
Charleston, South Carolina, Verenigde Staten
- Research Site
-
Columbia, South Carolina, Verenigde Staten
- Research Site
-
Greenville, South Carolina, Verenigde Staten
- Research Site
-
-
South Dakota
-
Rapid City, South Dakota, Verenigde Staten
- Research Site
-
-
Tennessee
-
Jackson, Tennessee, Verenigde Staten
- Research Site
-
Knoxville, Tennessee, Verenigde Staten
- Research Site
-
Memphis, Tennessee, Verenigde Staten
- Research Site
-
-
Texas
-
Amarillo, Texas, Verenigde Staten
- Research Site
-
Austin, Texas, Verenigde Staten
- Research Site
-
Dallas, Texas, Verenigde Staten
- Research Site
-
Houston, Texas, Verenigde Staten
- Research Site
-
Lubbock, Texas, Verenigde Staten
- Research Site
-
San Antonio, Texas, Verenigde Staten
- Research Site
-
San Marcos, Texas, Verenigde Staten
- Research Site
-
Tyler, Texas, Verenigde Staten
- Research Site
-
Victoria, Texas, Verenigde Staten
- Research Site
-
-
Vermont
-
Burlington, Vermont, Verenigde Staten
- Research Site
-
-
Virginia
-
Falls Church, Virginia, Verenigde Staten
- Research Site
-
Fredericksburg, Virginia, Verenigde Staten
- Research Site
-
Norfolk, Virginia, Verenigde Staten
- Research Site
-
Winchester, Virginia, Verenigde Staten
- Research Site
-
-
Washington
-
Everett, Washington, Verenigde Staten
- Research Site
-
Tacoma, Washington, Verenigde Staten
- Research Site
-
-
West Virginia
-
Morgantown, West Virginia, Verenigde Staten
- Research Site
-
-
Wisconsin
-
Green Bay, Wisconsin, Verenigde Staten
- Research Site
-
-
-
-
-
Cape Town, Zuid-Afrika
- Research Site
-
Pretoria, Zuid-Afrika
- Research Site
-
-
Cape Town
-
Somerset West, Cape Town, Zuid-Afrika
- Research Site
-
-
Free State
-
Bloemfontein, Free State, Zuid-Afrika
- Research Site
-
-
-
-
-
Boras, Zweden
- Research Site
-
Eksjo, Zweden
- Research Site
-
Eskilstuna, Zweden
- Research Site
-
Falun, Zweden
- Research Site
-
Halmstad, Zweden
- Research Site
-
Jonkoping, Zweden
- Research Site
-
Kalmar, Zweden
- Research Site
-
Karlskrona, Zweden
- Research Site
-
Lidkoping, Zweden
- Research Site
-
Linkoping, Zweden
- Research Site
-
Ljungby, Zweden
- Research Site
-
Lund, Zweden
- Research Site
-
Ostersund, Zweden
- Research Site
-
Skovde, Zweden
- Research Site
-
Stockholm, Zweden
- Research Site
-
Sundsvall, Zweden
- Research Site
-
Uppsala, Zweden
- Research Site
-
Vasteras, Zweden
- Research Site
-
-
-
-
-
Bellinzona, Zwitserland
- Research Site
-
Bern, Zwitserland
- Research Site
-
Geneve, Zwitserland
- Research Site
-
Kreuzlingen, Zwitserland
- Research Site
-
Lugano, Zwitserland
- Research Site
-
-
Ticino
-
Mendrisio, Ticino, Zwitserland
- Research Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
- Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception
Exclusion Criteria:
- Persons with moderate or severe liver disease
- Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
- Persons who are being treated with blood clotting agents that cannot be stopped
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Clopidogrel
Oral treatment
|
Clopidogrel 75 mg once daily dose (ODD)
Andere namen:
|
Experimenteel: Ticagrelor
Oral treatment
|
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Tijdsspanne: Randomization up to 12 months
|
Participants with death from vascular causes, MI, or stroke.
If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy.
Intention To Treat (ITT) analysis of whole population.
Events were adjudicated by an endpoint committee.
|
Randomization up to 12 months
|
Participants With Any Major Bleeding Event
Tijdsspanne: First dosing up to 12 months
|
Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors.
Events were adjudicated by an endpoint committee.
|
First dosing up to 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Tijdsspanne: Randomization up to 12 months
|
Participants with death from vascular causes, MI, or stroke.
If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy.
ITT analysis of intent for invasive management population.
Events were adjudicated by an endpoint committee.
|
Randomization up to 12 months
|
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Tijdsspanne: Randomization up to 12 months
|
Participants with death from any cause, MI, or stroke.
If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy.
ITT analysis of whole population.
Events were adjudicated by an endpoint committee.
|
Randomization up to 12 months
|
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Tijdsspanne: Randomization up to 12 months
|
Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events.
If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy.
ITT analysis of whole population.
Events were adjudicated.
|
Randomization up to 12 months
|
Participants With MI Event
Tijdsspanne: Randomization up to 12 months
|
Participants with MI event.
If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy.
ITT (intention to treat) analysis of whole population.
Events were adjudicated by an endpoint committee.
|
Randomization up to 12 months
|
Participants With Death From Vascular Causes
Tijdsspanne: Randomization up to 12 months
|
Participants with death from vascular causes.
If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy.
ITT (intention to treat) analysis of whole population.
Events were adjudicated by an endpoint committee.
|
Randomization up to 12 months
|
Participants With Stroke
Tijdsspanne: Randomization up to 12 months
|
Participants with stroke.
If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy.
ITT (intention to treat) analysis of whole population.
Events were adjudicated by an endpoint committee.
|
Randomization up to 12 months
|
Participants With Death From Any Cause
Tijdsspanne: Randomization up to 12 months
|
Participants with death from any cause.
If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy.
ITT (intention to treat) analysis of whole population.
Events were adjudicated by an endpoint committee.
|
Randomization up to 12 months
|
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
Tijdsspanne: First dosing up to 12 months
|
Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors.
Events were adjudicated by an endpoint committee.
|
First dosing up to 12 months
|
Participants With Major or Minor Bleeding
Tijdsspanne: First dosing up to 12 months
|
Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors.
Events were adjudicated by an endpoint committee.
|
First dosing up to 12 months
|
Participants With Non-procedural Major Bleeding
Tijdsspanne: First dosing up to 12 months
|
Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors.
Events were adjudicated by an endpoint committee.
|
First dosing up to 12 months
|
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Tijdsspanne: First dosing up to 12 months
|
Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors.
All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
|
First dosing up to 12 months
|
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Tijdsspanne: First dosing up to 12 months
|
Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors.
All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
|
First dosing up to 12 months
|
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Tijdsspanne: 1-week period following randomization
|
Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds.
Population is all patients who were observed over 2 week-long periods.
Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.
|
1-week period following randomization
|
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Tijdsspanne: 1-week period following randomization
|
Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds.
Population is all patients who were observed over 2 week-long periods.
Pauses were flagged algorithmically and confirmed by TIMI cardiologists.
|
1-week period following randomization
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Jonathan C. Fox, MD, AstraZeneca
- Hoofdonderzoeker: Robert Harrington, MD, Duke Clinical Research Institute
- Hoofdonderzoeker: Lars Wallentin, MD, Uppsala Clinical Research Centre
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
- Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
- Mahmoodi BK, Eriksson N, Vos GJA, Meijer K, Siegbahn A, James S, Wallentin L, Ten Berg JM. Factor V Leiden Does Not Modify the Phenotype of Acute Coronary Syndrome or the Extent of Myocardial Necrosis. J Am Heart Assoc. 2021 Jun;10(11):e020025. doi: 10.1161/JAHA.120.020025. Epub 2021 May 17.
- Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.
- Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.
- Samman KN, Mehanna P, Takla E, Grenier JC, Chan MY, Lopes RD, Neely ML, Wang TY, Newby LK, Becker RC, Lordkipanidze M, Ruiz M, Hussin JG, Jolicoeur EM. Differential modulation of polyunsaturated fatty acids in patients with myocardial infarction treated with ticagrelor or clopidogrel. Cell Rep Med. 2021 Jun 4;2(6):100299. doi: 10.1016/j.xcrm.2021.100299. eCollection 2021 Jun 15.
- Thi Thu Nguyen T, Van Do D, Mellstrom C, Quang Nguyen T, Manh Pham H, Van Hoang S, Cong Luu T, Le Phuong T. Cost-Effectiveness of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome from Vietnamese Healthcare Payers' Perspective. Adv Ther. 2021 Jul;38(7):4026-4039. doi: 10.1007/s12325-021-01743-5. Epub 2021 Jun 11.
- Gregersen I, Michelsen AE, Lunde NN, Akerblom A, Lakic TG, Skjelland M, Ryeng Skagen K, Becker RC, Lindback J, Himmelmann A, Solberg R, Johansen HT, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Ueland T, Wallentin L, Halvorsen B. Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2020 Sep;9(17):e016360. doi: 10.1161/JAHA.120.016360. Epub 2020 Aug 15.
- Sumaya W, Wallentin L, James SK, Siegbahn A, Gabrysch K, Himmelmann A, Ajjan RA, Storey RF. Impaired Fibrinolysis Predicts Adverse Outcome in Acute Coronary Syndrome Patients with Diabetes: A PLATO Sub-Study. Thromb Haemost. 2020 Mar;120(3):412-422. doi: 10.1055/s-0039-1701011. Epub 2020 Jan 23.
- Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Becker RC, Bertilsson M, Budaj A, Cornel JH, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Wallentin L; PLATO Investigators. ALCAM predicts future cardiovascular death in acute coronary syndromes: Insights from the PLATO trial. Atherosclerosis. 2020 Jan;293:35-41. doi: 10.1016/j.atherosclerosis.2019.11.031. Epub 2019 Nov 29.
- Andersen T, Ueland T, Ghukasyan Lakic T, Akerblom A, Bertilsson M, Aukrust P, Michelsen AE, James SK, Becker RC, Storey RF, Wallentin L, Siegbahn A, Kontny F. C-X-C Ligand 16 Is an Independent Predictor of Cardiovascular Death and Morbidity in Acute Coronary Syndromes. Arterioscler Thromb Vasc Biol. 2019 Nov;39(11):2402-2410. doi: 10.1161/ATVBAHA.119.312633. Epub 2019 Sep 26.
- Akerblom A, Wojdyla DM, Wallentin L, James SK, de Souza Brito F, Steg PG, Cannon CP, Katus HA, Himmelmann A, Storey RF, Becker RC, Lopes RD; PLATO Investigators. Ticagrelor in patients with heart failure after acute coronary syndromes-Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2019 Jul;213:57-65. doi: 10.1016/j.ahj.2019.04.006. Epub 2019 Apr 18.
- Franchi F, James SK, Ghukasyan Lakic T, Budaj AJ, Cornel JH, Katus HA, Keltai M, Kontny F, Lewis BS, Storey RF, Himmelmann A, Wallentin L, Angiolillo DJ; PLATO Investigators. Impact of Diabetes Mellitus and Chronic Kidney Disease on Cardiovascular Outcomes and Platelet P2Y12 Receptor Antagonist Effects in Patients With Acute Coronary Syndromes: Insights From the PLATO Trial. J Am Heart Assoc. 2019 Mar 19;8(6):e011139. doi: 10.1161/JAHA.118.011139.
- Lindholm D, James SK, Gabrysch K, Storey RF, Himmelmann A, Cannon CP, Mahaffey KW, Steg PG, Held C, Siegbahn A, Wallentin L. Association of Multiple Biomarkers With Risk of All-Cause and Cause-Specific Mortality After Acute Coronary Syndromes: A Secondary Analysis of the PLATO Biomarker Study. JAMA Cardiol. 2018 Dec 1;3(12):1160-1166. doi: 10.1001/jamacardio.2018.3811.
- Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Aukrust P, Becker RC, Bertilsson M, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Wallentin L; PLATO (Platelet Inhibition and Patient Outcomes) Trial Investigators. Osteoprotegerin Is Associated With Major Bleeding But Not With Cardiovascular Outcomes in Patients With Acute Coronary Syndromes: Insights From the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2018 Jan 12;7(2):e007009. doi: 10.1161/JAHA.117.007009.
- Bellavia A, Wallentin L, Orsini N, James SK, Cannon CP, Himmelmann A, Sundstrom J, Renlund H, Lytsy P. Time-based measures of treatment effect: reassessment of ticagrelor and clopidogrel from the PLATO trial. Open Heart. 2017 Jun 1;4(2):e000557. doi: 10.1136/openhrt-2016-000557. eCollection 2017.
- Lindholm D, Hagstrom E, James SK, Becker RC, Cannon CP, Himmelmann A, Katus HA, Maurer G, Lopez-Sendon JL, Steg PG, Storey RF, Siegbahn A, Wallentin L. Growth Differentiation Factor 15 at 1 Month After an Acute Coronary Syndrome Is Associated With Increased Risk of Major Bleeding. J Am Heart Assoc. 2017 Apr 14;6(4):e005580. doi: 10.1161/JAHA.117.005580.
- Lindholm D, James SK, Bertilsson M, Becker RC, Cannon CP, Giannitsis E, Harrington RA, Himmelmann A, Kontny F, Siegbahn A, Steg PG, Storey RF, Velders MA, Weaver WD, Wallentin L; PLATO Investigators. Biomarkers and Coronary Lesions Predict Outcomes after Revascularization in Non-ST-Elevation Acute Coronary Syndrome. Clin Chem. 2017 Feb;63(2):573-584. doi: 10.1373/clinchem.2016.261271. Epub 2016 Dec 8.
- Johansson A, Eriksson N, Lindholm D, Varenhorst C, James S, Syvanen AC, Axelsson T, Siegbahn A, Barratt BJ, Becker RC, Himmelmann A, Katus HA, Steg PG, Storey RF, Wallentin L; PLATO Investigators. Genome-wide association and Mendelian randomization study of NT-proBNP in patients with acute coronary syndrome. Hum Mol Genet. 2016 Apr 1;25(7):1447-56. doi: 10.1093/hmg/ddw012. Epub 2016 Jan 21.
- Velders MA, Abtan J, Angiolillo DJ, Ardissino D, Harrington RA, Hellkamp A, Himmelmann A, Husted S, Katus HA, Meier B, Schulte PJ, Storey RF, Wallentin L, Gabriel Steg P, James SK; PLATO Investigators. Safety and efficacy of ticagrelor and clopidogrel in primary percutaneous coronary intervention. Heart. 2016 Apr;102(8):617-25. doi: 10.1136/heartjnl-2015-308963. Epub 2016 Feb 4.
- Bui AH, Cannon CP, Steg PG, Storey RF, Husted S, Guo J, Im K, James SK, Michelson EL, Himmelmann A, Held C, Varenhorst C, Wallentin L, Scirica BM. Relationship Between Early and Late Nonsustained Ventricular Tachycardia and Cardiovascular Death in Patients With Acute Coronary Syndrome in the Platelet Inhibition and Patient Outcomes (PLATO) Trial. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e002951. doi: 10.1161/CIRCEP.115.002951.
- Andell P, James SK, Cannon CP, Cyr DD, Himmelmann A, Husted S, Keltai M, Koul S, Santoso A, Steg PG, Storey RF, Wallentin L, Erlinge D; PLATO Investigators. Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes and Chronic Obstructive Pulmonary Disease: An Analysis From the Platelet Inhibition and Patient Outcomes (PLATO) Trial. J Am Heart Assoc. 2015 Oct 9;4(10):e002490. doi: 10.1161/JAHA.115.002490.
- Hagstrom E, James SK, Bertilsson M, Becker RC, Himmelmann A, Husted S, Katus HA, Steg PG, Storey RF, Siegbahn A, Wallentin L; PLATO Investigators. Growth differentiation factor-15 level predicts major bleeding and cardiovascular events in patients with acute coronary syndromes: results from the PLATO study. Eur Heart J. 2016 Apr 21;37(16):1325-33. doi: 10.1093/eurheartj/ehv491. Epub 2015 Sep 28.
- Kang HJ, Clare RM, Gao R, Held C, Himmelmann A, James SK, Lim ST, Santoso A, Yu CM, Wallentin L, Becker RC; PLATO Investigators. Ticagrelor versus clopidogrel in Asian patients with acute coronary syndrome: A retrospective analysis from the Platelet Inhibition and Patient Outcomes (PLATO) Trial. Am Heart J. 2015 Jun;169(6):899-905.e1. doi: 10.1016/j.ahj.2015.03.015. Epub 2015 Mar 31.
- Velders MA, Wallentin L, Becker RC, van Boven AJ, Himmelmann A, Husted S, Katus HA, Lindholm D, Morais J, Siegbahn A, Storey RF, Wernroth L, James SK; PLATO Investigators. Biomarkers for risk stratification of patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention: Insights from the Platelet Inhibition and Patient Outcomes trial. Am Heart J. 2015 Jun;169(6):879-889.e7. doi: 10.1016/j.ahj.2015.02.019. Epub 2015 Mar 5.
- Varenhorst C, Eriksson N, Johansson A, Barratt BJ, Hagstrom E, Akerblom A, Syvanen AC, Becker RC, James SK, Katus HA, Husted S, Steg PG, Siegbahn A, Voora D, Teng R, Storey RF, Wallentin L; PLATO Investigators. Effect of genetic variations on ticagrelor plasma levels and clinical outcomes. Eur Heart J. 2015 Aug 1;36(29):1901-12. doi: 10.1093/eurheartj/ehv116. Epub 2015 May 2.
- Kholaif N, Zheng Y, Jagasia P, Himmelmann A, James SK, Steg PG, Storey RF, Westerhout CM, Armstrong PW. Baseline Q waves and time from symptom onset to ST-segment elevation myocardial infarction: insights from PLATO on the influence of sex. Am J Med. 2015 Aug;128(8):914.e11-9. doi: 10.1016/j.amjmed.2015.03.005. Epub 2015 Mar 26.
- Cowper PA, Pan W, Anstrom KJ, Kaul P, Wallentin L, Davidson-Ray L, Nikolic E, Janzon M, Levin LA, Cannon CP, Harrington RA, Mark DB. Economic analysis of ticagrelor therapy from a U.S. perspective: results from the PLATO study. J Am Coll Cardiol. 2015 Feb 10;65(5):465-76. doi: 10.1016/j.jacc.2014.11.034.
- Janzon M, James S, Cannon CP, Storey RF, Mellstrom C, Nicolau JC, Wallentin L, Henriksson M. Health economic analysis of ticagrelor in patients with acute coronary syndromes intended for non-invasive therapy. Heart. 2015 Jan;101(2):119-25. doi: 10.1136/heartjnl-2014-305864. Epub 2014 Sep 16.
- Varenhorst C, Alstrom U, Braun OO, Storey RF, Mahaffey KW, Bertilsson M, Cannon CP, Scirica BM, Himmelmann A, James SK, Wallentin L, Held C. Causes of mortality with ticagrelor compared with clopidogrel in acute coronary syndromes. Heart. 2014 Nov;100(22):1762-9. doi: 10.1136/heartjnl-2014-305619. Epub 2014 Jun 23.
- Kotsia A, Brilakis ES, Held C, Cannon C, Steg GP, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, James SK. Extent of coronary artery disease and outcomes after ticagrelor administration in patients with an acute coronary syndrome: Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2014 Jul;168(1):68-75.e2. doi: 10.1016/j.ahj.2014.04.001. Epub 2014 Apr 13.
- Patel MR, Becker RC, Wojdyla DM, Emanuelsson H, Hiatt WR, Horrow J, Husted S, Mahaffey KW, Steg PG, Storey RF, Wallentin L, James SK. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared with clopidogrel: Data from the PLATO Trial. Eur J Prev Cardiol. 2015 Jun;22(6):734-42. doi: 10.1177/2047487314533215. Epub 2014 May 15.
- Husted S, James SK, Bach RG, Becker RC, Budaj A, Heras M, Himmelmann A, Horrow J, Katus HA, Lassila R, Morais J, Nicolau JC, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATO study group. The efficacy of ticagrelor is maintained in women with acute coronary syndromes participating in the prospective, randomized, PLATelet inhibition and patient Outcomes (PLATO) trial. Eur Heart J. 2014 Jun 14;35(23):1541-50. doi: 10.1093/eurheartj/ehu075. Epub 2014 Mar 28.
- Mahaffey KW, Held C, Wojdyla DM, James SK, Katus HA, Husted S, Steg PG, Cannon CP, Becker RC, Storey RF, Khurmi NS, Nicolau JC, Yu CM, Ardissino D, Budaj A, Morais J, Montgomery D, Himmelmann A, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol. 2014 Apr 22;63(15):1493-9. doi: 10.1016/j.jacc.2014.01.038. Epub 2014 Feb 19.
- Wallentin L, Lindholm D, Siegbahn A, Wernroth L, Becker RC, Cannon CP, Cornel JH, Himmelmann A, Giannitsis E, Harrington RA, Held C, Husted S, Katus HA, Mahaffey KW, Steg PG, Storey RF, James SK; PLATO study group. Biomarkers in relation to the effects of ticagrelor in comparison with clopidogrel in non-ST-elevation acute coronary syndrome patients managed with or without in-hospital revascularization: a substudy from the Prospective Randomized Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2014 Jan 21;129(3):293-303. doi: 10.1161/CIRCULATIONAHA.113.004420. Epub 2013 Oct 29.
- Brilakis ES, Held C, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, James SK. Effect of ticagrelor on the outcomes of patients with prior coronary artery bypass graft surgery: insights from the PLATelet inhibition and patient outcomes (PLATO) trial. Am Heart J. 2013 Sep;166(3):474-80. doi: 10.1016/j.ahj.2013.06.019. Epub 2013 Jul 26.
- Steg PG, Harrington RA, Emanuelsson H, Katus HA, Mahaffey KW, Meier B, Storey RF, Wojdyla DM, Lewis BS, Maurer G, Wallentin L, James SK; PLATO Study Group. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial. Circulation. 2013 Sep 3;128(10):1055-65. doi: 10.1161/CIRCULATIONAHA.113.002589. Epub 2013 Jul 30.
- Kunadian V, James SK, Wojdyla DM, Zorkun C, Wu J, Storey RF, Steg PG, Katus H, Emanuelsson H, Horrow J, Maya J, Wallentin L, Harrington RA, Gibson CM. Angiographic outcomes in the PLATO Trial (Platelet Inhibition and Patient Outcomes). JACC Cardiovasc Interv. 2013 Jul;6(7):671-83. doi: 10.1016/j.jcin.2013.03.014.
- James SK, Storey RF, Pieper KS, Cannon CP, Becker RC, Steg PG, Wallentin L, Harrington RA; PLATO Study Group. Response to letter regarding article, "Ticagrelor in patients with acute coronary syndromes and stroke: interpretation of subgroups in clinical trials". Stroke. 2013 Aug;44(8):e95-6. doi: 10.1161/STROKEAHA.113.002069. Epub 2013 Jun 25. No abstract available.
- James SK, Pieper KS, Cannon CP, Storey RF, Becker RC, Steg PG, Wallentin L, Harrington RA; PLATO study group. Ticagrelor in patients with acute coronary syndromes and stroke: interpretation of subgroups in clinical trials. Stroke. 2013 May;44(5):1477-9. doi: 10.1161/STROKEAHA.111.000514. Epub 2013 Apr 9. No abstract available.
- Kohli P, Wallentin L, Reyes E, Horrow J, Husted S, Angiolillo DJ, Ardissino D, Maurer G, Morais J, Nicolau JC, Oto A, Storey RF, James SK, Cannon CP. Reduction in first and recurrent cardiovascular events with ticagrelor compared with clopidogrel in the PLATO Study. Circulation. 2013 Feb 12;127(6):673-80. doi: 10.1161/CIRCULATIONAHA.112.124248. Epub 2012 Dec 31.
- Akerblom A, Wallentin L, Siegbahn A, Becker RC, Budaj A, Horrow J, Husted S, Katus H, Claeys MJ, Storey RF, Asenblad N, James SK. Outcome and causes of renal deterioration evaluated by serial cystatin C measurements in acute coronary syndrome patients -- results from the PLATelet inhibition and patient Outcomes (PLATO) study. Am Heart J. 2012 Nov;164(5):728-34. doi: 10.1016/j.ahj.2012.08.017. Epub 2012 Oct 17.
- Varenhorst C, Alstrom U, Scirica BM, Hogue CW, Asenblad N, Storey RF, Steg PG, Horrow J, Mahaffey KW, Becker RC, James S, Cannon CP, Brandrup-Wognsen G, Wallentin L, Held C. Factors contributing to the lower mortality with ticagrelor compared with clopidogrel in patients undergoing coronary artery bypass surgery. J Am Coll Cardiol. 2012 Oct 23;60(17):1623-30. doi: 10.1016/j.jacc.2012.07.021. Epub 2012 Sep 26.
- Husted S, James S, Becker RC, Horrow J, Katus H, Storey RF, Cannon CP, Heras M, Lopes RD, Morais J, Mahaffey KW, Bach RG, Wojdyla D, Wallentin L; PLATO study group. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet inhibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):680-8. doi: 10.1161/CIRCOUTCOMES.111.964395.
- Cornel JH, Becker RC, Goodman SG, Husted S, Katus H, Santoso A, Steg G, Storey RF, Vintila M, Sun JL, Horrow J, Wallentin L, Harrington R, James S. Prior smoking status, clinical outcomes, and the comparison of ticagrelor with clopidogrel in acute coronary syndromes-insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2012 Sep;164(3):334-342.e1. doi: 10.1016/j.ahj.2012.06.005. Epub 2012 Jul 26.
- Nikolic E, Janzon M, Hauch O, Wallentin L, Henriksson M; PLATO Health Economic Substudy Group. Cost-effectiveness of treating acute coronary syndrome patients with ticagrelor for 12 months: results from the PLATO study. Eur Heart J. 2013 Jan;34(3):220-8. doi: 10.1093/eurheartj/ehs149. Epub 2012 Jun 19.
- James SK, Storey RF, Khurmi NS, Husted S, Keltai M, Mahaffey KW, Maya J, Morais J, Lopes RD, Nicolau JC, Pais P, Raev D, Lopez-Sendon JL, Stevens SR, Becker RC; PLATO Study Group. Ticagrelor versus clopidogrel in patients with acute coronary syndromes and a history of stroke or transient ischemic attack. Circulation. 2012 Jun 12;125(23):2914-21. doi: 10.1161/CIRCULATIONAHA.111.082727. Epub 2012 May 9.
- Siha H, Das D, Fu Y, Zheng Y, Westerhout CM, Storey RF, James S, Wallentin L, Armstrong PW. Baseline Q waves as a prognostic modulator in patients with ST-segment elevation: insights from the PLATO trial. CMAJ. 2012 Jul 10;184(10):1135-42. doi: 10.1503/cmaj.111683. Epub 2012 Apr 30.
- Goodman SG, Clare R, Pieper KS, Nicolau JC, Storey RF, Cantor WJ, Mahaffey KW, Angiolillo DJ, Husted S, Cannon CP, James SK, Kilhamn J, Steg PG, Harrington RA, Wallentin L; Platelet Inhibition and Patient Outcomes Trial Investigators. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation. 2012 Feb 28;125(8):978-86. doi: 10.1161/CIRCULATIONAHA.111.032912. Epub 2012 Jan 18.
- Armstrong PW, Siha H, Fu Y, Westerhout CM, Steg PG, James SK, Storey RF, Horrow J, Katus H, Clemmensen P, Harrington RA, Wallentin L. ST-elevation acute coronary syndromes in the Platelet Inhibition and Patient Outcomes (PLATO) trial: insights from the ECG substudy. Circulation. 2012 Jan 24;125(3):514-21. doi: 10.1161/CIRCULATIONAHA.111.047530. Epub 2011 Dec 16.
- Becker RC, Bassand JP, Budaj A, Wojdyla DM, James SK, Cornel JH, French J, Held C, Horrow J, Husted S, Lopez-Sendon J, Lassila R, Mahaffey KW, Storey RF, Harrington RA, Wallentin L. Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial. Eur Heart J. 2011 Dec;32(23):2933-44. doi: 10.1093/eurheartj/ehr422. Epub 2011 Nov 16. Erratum In: Eur Heart J. 2012 Nov;33(21):2750.
- Mahaffey KW, Wojdyla DM, Carroll K, Becker RC, Storey RF, Angiolillo DJ, Held C, Cannon CP, James S, Pieper KS, Horrow J, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2011 Aug 2;124(5):544-54. doi: 10.1161/CIRCULATIONAHA.111.047498. Epub 2011 Jun 27.
- James SK, Roe MT, Cannon CP, Cornel JH, Horrow J, Husted S, Katus H, Morais J, Steg PG, Storey RF, Stevens S, Wallentin L, Harrington RA; PLATO Study Group. Ticagrelor versus clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomised PLATelet inhibition and patient Outcomes (PLATO) trial. BMJ. 2011 Jun 17;342:d3527. doi: 10.1136/bmj.d3527.
- Scirica BM, Cannon CP, Emanuelsson H, Michelson EL, Harrington RA, Husted S, James S, Katus H, Pais P, Raev D, Spinar J, Steg PG, Storey RF, Wallentin L; PLATO Investigators. The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiographic assessment substudy. J Am Coll Cardiol. 2011 May 10;57(19):1908-16. doi: 10.1016/j.jacc.2010.11.056.
- Steg PG, James S, Harrington RA, Ardissino D, Becker RC, Cannon CP, Emanuelsson H, Finkelstein A, Husted S, Katus H, Kilhamn J, Olofsson S, Storey RF, Weaver WD, Wallentin L; PLATO Study Group. Ticagrelor versus clopidogrel in patients with ST-elevation acute coronary syndromes intended for reperfusion with primary percutaneous coronary intervention: A Platelet Inhibition and Patient Outcomes (PLATO) trial subgroup analysis. Circulation. 2010 Nov 23;122(21):2131-41. doi: 10.1161/CIRCULATIONAHA.109.927582. Epub 2010 Nov 8.
- James S, Budaj A, Aylward P, Buck KK, Cannon CP, Cornel JH, Harrington RA, Horrow J, Katus H, Keltai M, Lewis BS, Parikh K, Storey RF, Szummer K, Wojdyla D, Wallentin L. Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2010 Sep 14;122(11):1056-67. doi: 10.1161/CIRCULATIONAHA.109.933796. Epub 2010 Aug 30.
- Cannon CP, Harrington RA, James S, Ardissino D, Becker RC, Emanuelsson H, Husted S, Katus H, Keltai M, Khurmi NS, Kontny F, Lewis BS, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATelet inhibition and patient Outcomes Investigators. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study. Lancet. 2010 Jan 23;375(9711):283-93. doi: 10.1016/S0140-6736(09)62191-7. Epub 2010 Jan 13.
- Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Molecule of the month. Ticagrelor. Drug News Perspect. 2007 May;20(4):264. No abstract available.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2006
Primaire voltooiing (Werkelijk)
1 maart 2009
Studie voltooiing (Werkelijk)
1 maart 2009
Studieregistratiedata
Eerst ingediend
23 oktober 2006
Eerst ingediend dat voldeed aan de QC-criteria
23 oktober 2006
Eerst geplaatst (Schatting)
25 oktober 2006
Updates van studierecords
Laatste update geplaatst (Schatting)
13 maart 2012
Laatste update ingediend die voldeed aan QC-criteria
10 februari 2012
Laatst geverifieerd
1 februari 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Myocardiale ischemie
- Hartziekten
- Hart-en vaatziekten
- Vaatziekten
- Ziekte
- Syndroom
- Acute kransslagader syndroom
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Bloedplaatjesaggregatieremmers
- Purinerge P2Y-receptorantagonisten
- Purinerge P2-receptorantagonisten
- Purinerge antagonisten
- Purinerge middelen
- Ticagrelor
- Clopidogrel
Andere studie-ID-nummers
- D5130C05262
- PLATO
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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