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 - PEGASUS - TIMI 54

AstraZeneca AB0 sites21,162 target enrollmentOctober 27, 2010

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2010

End Date

December 3, 2014

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Men and women \=50 years of age.
•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 and be willing to use medically accepted method of contraception.
•Patient must be currently taking aspirin, with a planned maintenance dose between 75 and 150 mg once daily.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 7000
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 14000

•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.