None listed
Conditions
Interventions
Group 1 Type of group
Patients will receive ticagrelor 90 mg oral bd for a minimum of 12 months.
Group name:Group 3 Type of group
Patients will receive placebo for a minimum of 12 months.
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction. • Females of child-bearing potential must have a negative pregnancy test at enrollment • Persons who are currently taking aspirin between 75 and 150 mg once daily
Exclusion criteria
Exclusion criteria: • Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start • Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start • Persons with known bleeding disorders • Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin • Persons with a history of ischemic stroke • Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days. • Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker • Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery • Persons with known severe liver disease • Persons with kidney failure requiring dialysis • Persons with life expectancy < 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization Measure:Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization Timepoints:Randomization up to 47 months ; Outcome name:A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug Measure: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 Timepoints:First dosing up to 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization Measure:Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization Timepoints:Randomization up to 47 months ; Outcome name:Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization Measure:Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization Timepoints:Randomization up to 47 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hungary, India, Italy, Japan, Korea South, Netherlands, Norway, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kindgdom, United States
Outcome results
None listed