Health Condition 1: null- Prevention of future cardiovascular events in patients with previous Myocardial Infarction
Conditions
Interventions
Intervention1: Ticagrelor 90 mg: oral, twice daily, 38 months
Intervention2: Ticagrelor 60 mg: oral, twice daily, 38 months
Intervention3: Ticagrelor Placebo: oral, twice daily, 38 months
Control Inte
Sponsors
AstraZeneca Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: - Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ¡Ý 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 |
|---|---|
| Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke.Timepoint: Within 1 year to 38 months | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality after randomizationTimepoint: Within 1 year to 38 months;Cardiovascular death after randomizationTimepoint: Within 1 year to 38 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Ramesh Jagannathan
AstraZeneca Pharma India Ltd
Outcome results
None listed