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

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ClinicalTrials.gov Identifier: NCT00391872
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : March 13, 2012
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 23, 2006
First Posted Date  ICMJE October 25, 2006
Results First Submitted Date January 31, 2011
Results First Posted Date March 13, 2012
Last Update Posted Date March 13, 2012
Study Start Date  ICMJE October 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke [ Time Frame: 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.
  • Participants With Any Major Bleeding Event [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2006)		 The primary outcome measure will be the reduction in the relative risk of vascular death, nonfatal myocardial infarction, or nonfatal stroke (composite primary endpoint), comparing AZD6140 to clopidogrel in patients with non-ST or ST elevation ACS.
Change History Complete list of historical versions of study NCT00391872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2006)		 Secondary outcomes will include the individual event categories from the primary composite endpoint, a variety of other important clinical outcomes related to ACS, and assessment of the overall safety and tolerability of AZD6140 compared to clopidogrel.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
Official Title  ICMJE 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]
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Ticagrelor
    Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
    Other Name: AZD6140
  • Drug: Clopidogrel
    Clopidogrel 75 mg once daily dose (ODD)
    Other Name: Plavix®
Study Arms
  • Active Comparator: Clopidogrel
    Oral treatment
    Intervention: Drug: Clopidogrel
  • Experimental: Ticagrelor
    Oral treatment
    Intervention: Drug: Ticagrelor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2012)		 18624
Original Enrollment  ICMJE
 (submitted: October 23, 2006)		 18000
Actual Study Completion Date March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   Denmark,   Finland,   France,   Georgia,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Indonesia,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00391872
Other Study ID Numbers  ICMJE D5130C05262
PLATO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account AstraZeneca
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP