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

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: Clopidogrel 75 mg once daily dose (ODD)
    ARM 1: Kind: Experimental
    Label: 1
    Description: Clopidogrel
    ARM 2: Kind: Experimental
    Label: Clopidogrel
    Description: Oral treatment
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • AZD6140 Drug
    Intervention Desc: oral treatment
    ARM 1: Kind: Experimental
    Label: 2
    Description: AZD6140
  • Ticagrelor Drug
    Intervention Desc: Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
    ARM 1: Kind: Experimental
    Label: Ticagrelor
    Description: Oral treatment

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: 1: Active Comparator arm with Clopidogrel oral or 2: Experimental arm with AZD6140 oral.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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.
Secondary 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.
Primary 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. assessed after treatment Yes
Secondary 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. assessed after treatment No
Primary Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke Randomization up to 12 months No
Primary Participants With Any Major Bleeding Event First dosing up to 12 months Yes
Secondary 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 Randomization up to 12 months No
Secondary Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke Randomization up to 12 months No
Secondary 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. Randomization up to 12 months No
Secondary Participants With MI Event Randomization up to 12 months No
Secondary Participants With Death From Vascular Causes Randomization up to 12 months No
Secondary Participants With Stroke Randomization up to 12 months No
Secondary Participants With Death From Any Cause Randomization up to 12 months No
Secondary Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding First dosing up to 12 months Yes
Secondary Participants With Major or Minor Bleeding First dosing up to 12 months Yes
Secondary Participants With Non-procedural Major Bleeding First dosing up to 12 months Yes
Secondary Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding First dosing up to 12 months   Yes
Secondary Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding First dosing up to 12 months Yes
Secondary 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 1-week period following randomization Yes
Secondary 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 1-week period following randomization Yes

Sponsors