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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2013
• Main ID: NCT01225562
• Date of registration: 09/07/2010
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction
• Date of first enrolment: October 2010
• Target sample size: 21000
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01225562
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: AstraZeneca Clinical Study Information

• Name: Eugene Braunwald, MD
• Affiliation: TIMI Study Group

• Name: Marc Sabatine, MD, MPh
• Affiliation: TIMI Study Group

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atherothrombosis

Cardiovascular Death

Myocardial Infarction

Stroke

Intervention(s)

Drug: Ticagrelor 60 mg

Drug: Ticagrelor 90 mg

Drug: Ticagrelor Placebo

Primary Outcome(s)

Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. [Time Frame: Within 1 year to 38 months]

Secondary Outcome(s)

All-cause mortality after randomization [Time Frame: Within 1 year to 38 months]

Cardiovascular death after randomization [Time Frame: Within 1 year to 38 months]

Secondary ID(s)

2009-017242-30

D5132C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors