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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Ticagrelor Drug: Clopidogrel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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]
Study Start Date : October 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391872


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00391872    
Other Study ID Numbers: D5130C05262
PLATO
First Posted: October 25, 2006    Key Record Dates
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012
Last Verified: February 2012
Keywords provided by AstraZeneca:
ACS
Acute coronary syndrome
Heart attack
Unstable angina
Coronary artery disease
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
 Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs