A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome (PLATO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00391872
First received: October 23, 2006
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Ticagrelor
Drug: Clopidogrel
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Any Major Bleeding Event [ Time Frame: First dosing up to 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • 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. [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With MI Event [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Death From Vascular Causes [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Stroke [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Death From Any Cause [ Time Frame: Randomization up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding [ Time Frame: First dosing up to 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Participants With Major or Minor Bleeding [ Time Frame: First dosing up to 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Participants With Non-procedural Major Bleeding [ Time Frame: First dosing up to 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding [ Time Frame: First dosing up to 12 months   ] [ Designated as safety issue: Yes ]
    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.

  • Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding [ Time Frame: First dosing up to 12 months ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: 1-week period following randomization ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: 1-week period following randomization ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 18624
Study Start Date: October 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clopidogrel
Oral treatment
Drug: Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)
Other Name: Plavix®
Experimental: Ticagrelor
Oral treatment
Drug: Ticagrelor
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
Other Name: AZD6140

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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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: NCT00391872

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Kolkata, West Bengal, India
Indonesia
Research Site
Denpasar, Bali, Indonesia
Research Site
Bandung, Jawa Barat, Indonesia
Research Site
Surabaya, Jawa Timur, Indonesia
Research Site
Jakarta, Indonesia
Research Site
Makassar, Indonesia
Research Site
Semarang, Indonesia
Israel
Research Site
Afula, Israel
Research Site
Ashkelon, Israel
Research Site
Beer Sheva, Israel
Research Site
Hadera, Israel
Research Site
Haifa, Israel
Research Site
Holon, Israel
Research Site
Jerusalem, Israel
Research Site
Poriya M.p. Lower Galilee, Israel
Research Site
Rehovot, Israel
Research Site
Tel Aviv, Israel
Research Site
Zerifin, Israel
Italy
Research Site
Ancona, AN, Italy
Research Site
Bari, BA, Italy
Research Site
Bergamo, BG, Italy
Research Site
Caserta, CE, Italy
Research Site
Catania, CT, Italy
Research Site
Ferrara, FE, Italy
Research Site
Foggia, FG, Italy
Research Site
San Giovanni Rotondo, FG, Italy
Research Site
Bagno A Ripoli, FI, Italy
Research Site
Firenze, FI, Italy
Research Site
Legnano, MI, Italy
Research Site
Milano, MI, Italy
Research Site
Monza, MI, Italy
Research Site
Rozzano, MI, Italy
Research Site
Mantova, MN, Italy
Research Site
Modena, MO, Italy
Research Site
Pescara, PE, Italy
Research Site
Parma, PR, Italy
Research Site
Pavia, PV, Italy
Research Site
Ostia Lido, Roma, Italy
Research Site
Sassari, SS, Italy
Research Site
Treviso, TV, Italy
Research Site
Varese, VA, Italy
Research Site
Mestre, VE, Italy
Research Site
Verona, VR, Italy
Research Site
Massa Carrara, Italy
Research Site
Napoli, Italy
Research Site
Novara, Italy
Research Site
Roma, Italy
Korea, Republic of
Research Site
Seongnam, Gyeonggido, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon, Korea, Republic of
Research Site
Wonju, Korea, Republic of
Malaysia
Research Site
Kuching, Sarawak, Malaysia
Research Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Research Site
Penang, Malaysia
Mexico
Research Site
Mexico, Distrito Federal, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Monterrey, Nuevo Leon, Mexico
Research Site
Durango, Mexico
Research Site
Puebla, Mexico
Netherlands
Research Site
Alkmaar, Netherlands
Research Site
Almelo, Netherlands
Research Site
Amersfoort, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Apeldoorn, Netherlands
Research Site
Arnhem, Netherlands
Research Site
Assen, Netherlands
Research Site
Blaricum, Netherlands
Research Site
Breda, Netherlands
Research Site
Capelle Aan Den Ijssel, Netherlands
Research Site
Delft, Netherlands
Research Site
Den Haag, Netherlands
Research Site
Deventer, Netherlands
Research Site
Dordrecht, Netherlands
Research Site
Drachten, Netherlands
Research Site
EDE, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Goes, Netherlands
Research Site
Gorinchem, Netherlands
Research Site
Gouda, Netherlands
Research Site
Haarlem, Netherlands
Research Site
Hardenberg, Netherlands
Research Site
Harderwijk, Netherlands
Research Site
Heerlen, Netherlands
Research Site
Helmond, Netherlands
Research Site
Hilversum, Netherlands
Research Site
Leeuwarden, Netherlands
Research Site
Maastricht, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Spijkenisse, Netherlands
Research Site
Tiel, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Veldhoven, Netherlands
Research Site
Vlaardingen, Netherlands
Norway
Research Site
Arendal, Norway
Research Site
Bergen, Norway
Research Site
Bodo, Norway
Research Site
Drammen, Norway
Research Site
Flekkefjord, Norway
Research Site
Gjovik, Norway
Research Site
Hamar, Norway
Research Site
Kongsberg, Norway
Research Site
Kristiansand, Norway
Research Site
Lillehammer, Norway
Research Site
Nordbyhagen, Norway
Research Site
Notodden, Norway
Research Site
Oslo, Norway
Research Site
RUD, Norway
Research Site
Tromso, Norway
Research Site
Tynset, Norway
Philippines
Research Site
Cebu, Philippines
Research Site
Davao City, Philippines
Research Site
Manila, Philippines
Research Site
Pasig City, Philippines
Research Site
Quezon City, Philippines
Poland
Research Site
Bialystok, Poland
Research Site
Bielsko-biala, Poland
Research Site
Bydgoszcz, Poland
Research Site
Bytom, Poland
Research Site
Czestochowa, Poland
Research Site
Elblag, Poland
Research Site
Gda?sk, Poland
Research Site
Gdynia, Poland
Research Site
Grodzisk Mazowiecki, Poland
Research Site
Inowroclaw, Poland
Research Site
Katowice, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Olawa, Poland
Research Site
Olsztyn, Poland
Research Site
Opole, Poland
Research Site
Ostrowiec Swietokrzyski, Poland
Research Site
Plock, Poland
Research Site
Poznan, Poland
Research Site
Radom, Poland
Research Site
Szczecin, Poland
Research Site
Tarnow, Poland
Research Site
Torun, Poland
Research Site
Walbrzych, Poland
Research Site
Warszawa, Poland
Research Site
Wejherowo, Poland
Research Site
Wloclawek, Poland
Research Site
Wroclaw, Poland
Research Site
Zamosc, Poland
Portugal
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
Puerto Rico
Research Site
San Juan, Puerto Rico
Romania
Research Site
Pitesti, Arges, Romania
Research Site
Cluj Napoca, Cluj, Romania
Research Site
Braila, Romania
Research Site
Brasov, Romania
Research Site
Bucharest, Romania
Research Site
Buzau, Romania
Research Site
Craiova, Romania
Research Site
Iasi, Romania
Research Site
Suceava, Romania
Russian Federation
Research Site
Khanty-mansiysk, Khanty-mansiysk Autonomous Dis, Russian Federation
Research Site
Barnaul, Russian Federation
Research Site
Ekaterinburg, Russian Federation
Research Site
Irkutsk, Russian Federation
Research Site
Kaliningrad, Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Kemerovo, Russian Federation
Research Site
Krasnodar, Russian Federation
Research Site
Krasnoyarsk, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Murmansk, Russian Federation
Research Site
Nizhniy Novgorod, Russian Federation
Research Site
Novosibirsk, Russian Federation
Research Site
Rostov-na-donu, Russian Federation
Research Site
Samara, Russian Federation
Research Site
St. Petersburg, Russian Federation
Research Site
Tomsk, Russian Federation
Research Site
Tyumen, Russian Federation
Research Site
Vladivostok, Russian Federation
Singapore
Research Site
Singapore, Singapore
Slovakia
Research Site
Bratislava, Slovakia
Research Site
Kosice, Slovakia
Research Site
Liptovsky Mikulas, Slovakia
Research Site
Martin, Slovakia
Research Site
Nitra, Slovakia
Research Site
Nove Zamky, Slovakia
Research Site
Piestany, Slovakia
Research Site
Ruzomberok, Slovakia
Research Site
Trnava, Slovakia
Research Site
Zilina, Slovakia
South Africa
Research Site
Somerset West, Cape Town, South Africa
Research Site
Bloemfontein, Free State, South Africa
Research Site
Cape Town, South Africa
Research Site
Pretoria, South Africa
Spain
Research Site
Malaga, Andalucia, Spain
Research Site
Sevilla, Andalucia, Spain
Research Site
Gijon, Asturias, Spain
Research Site
Barcelona, Cataluna, Spain
Research Site
Lerida, Cataluna, Spain
Research Site
Terrassa, Cataluna, Spain
Research Site
Madrid, Comunidad de Madrid, Spain
Research Site
Valencia, Comunidad Valenciana, Spain
Research Site
Caceres, Extremadura, Spain
Research Site
Vigo(pontevedra), Galicia, Spain
Research Site
Palma de Mallorca, Islas Baleares, Spain
Sweden
Research Site
Boras, Sweden
Research Site
Eksjo, Sweden
Research Site
Eskilstuna, Sweden
Research Site
Falun, Sweden
Research Site
Halmstad, Sweden
Research Site
Jonkoping, Sweden
Research Site
Kalmar, Sweden
Research Site
Karlskrona, Sweden
Research Site
Lidkoping, Sweden
Research Site
Linkoping, Sweden
Research Site
Ljungby, Sweden
Research Site
Lund, Sweden
Research Site
Ostersund, Sweden
Research Site
Skovde, Sweden
Research Site
Stockholm, Sweden
Research Site
Sundsvall, Sweden
Research Site
Uppsala, Sweden
Research Site
Vasteras, Sweden
Switzerland
Research Site
Mendrisio, Ticino, Switzerland
Research Site
Bellinzona, Switzerland
Research Site
Bern, Switzerland
Research Site
Geneve, Switzerland
Research Site
Kreuzlingen, Switzerland
Research Site
Lugano, Switzerland
Taiwan
Research Site
Niao-song-shiang, Kaohsiung, Taiwan
Research Site
Kweishan Shiang, Taoyuan Hsien, Taiwan
Research Site
Taipei, Taiwan
Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Khon Kaen, Thailand
Turkey
Research Site
Istanbul, Kartal, Turkey
Research Site
Ankara, Sihhiye, Turkey
Research Site
Adana, Turkey
Research Site
Antalya, Turkey
Research Site
Mersin, Turkey
Ukraine
Research Site
Dnepropetrovsk, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kharkov, Ukraine
Research Site
Kiev, Ukraine
Research Site
Makiyivka, Ukraine
United Kingdom
Research Site
Airdrie, Lanarkshire, United Kingdom
Research Site
Belfast, Northern Ireland, United Kingdom
Research Site
Basingstoke, United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Blackpool, United Kingdom
Research Site
Dundee, United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Middlesborough, United Kingdom
Research Site
Poole, United Kingdom
Research Site
Sheffield, United Kingdom
Research Site
Swansea, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Robert Harrington, MD Duke Clinical Research Institute
Principal Investigator: Lars Wallentin, MD Uppsala Clinical Research Centre
Study Director: Jonathan C. Fox, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00391872     History of Changes
Other Study ID Numbers: D5130C05262, PLATO
Study First Received: October 23, 2006
Results First Received: January 31, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
ACS
Acute coronary syndrome
Heart attack
Unstable angina
Coronary artery disease

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticlopidine
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014