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)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Atherothrombosis; Stroke; Cardiovascular Death; Myocardial Infarction

Treatments: Drug: Ticagrelor 60 mg; Drug: Ticagrelor Placebo; Drug: Ticagrelor 90 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225562

2009-017242-30 (EudraCT Number)

D5132C00001

Details and patient eligibility

About

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).

Enrollment: 21,379 patients

Sex: All

Ages: 50 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21,379 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Oral Treatment

Treatment:

Drug: Ticagrelor 90 mg

2

Experimental group

Description:

Oral Treatment

Treatment:

Drug: Ticagrelor 60 mg

3

Placebo Comparator group

Description:

Oral Treatment

Treatment:

Drug: Ticagrelor Placebo