Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin "PEGASUS"

Completed

Phase 3 Results

Trial Description

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

Conditions

Interventions

  • Ticagrelor 90 mg Drug
    Intervention Desc: Oral dose twice a day
    ARM 1: Kind: Experimental
    Label: 1
    Description: Oral Treatment
  • Ticagrelor 60 mg Drug
    Other Names: Brilinta/Brilique
    Intervention Desc: Oral dose twice a day
    ARM 1: Kind: Experimental
    Label: 2
    Description: Oral Treatment
  • Ticagrelor Placebo Drug
    Intervention Desc: Oral dose twice a day
    ARM 1: Kind: Experimental
    Label: 3
    Description: Oral Treatment

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. Within 1 year to 38 months No
Secondary Cardiovascular death after randomization Within 1 year to 38 months No
Secondary All-cause mortality after randomization Within 1 year to 38 months No
Primary Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization Randomization up to 47 months No
Primary Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients First dosing up to 48 months Yes
Secondary Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization Randomization up to 47 months No
Secondary Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization Randomization up to 47 months No

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