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
Condition: Myocardial Infarction; Cardiovascular Death; Atherothrombosis; Stroke
MeSH terms: Myocardial Infarction; Infarction; Death
Intervention: Ticagrelor 90 mg; Ticagrelor 60 mg; Ticagrelor Placebo
Intervention description: Oral dose twice a day; Oral dose twice a day; Oral dose twice a day
Intervention MeSH terms: Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21379.0
Sex: All
Minimum age: 50 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Heart attack; Heart Disease; Acute coronary syndrome; ACS; Cardiovascular Disease

Summary:

      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).
    

Eligibility 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:

          -  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