PEGASUS - Ticagrelor Prevention of Thrombotic Events

• Research type

  Research Study

• Full title

  A Randomised, 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

• IRAS ID

  45341

• Contact name

  Robert Storey

• Eudract number

  2009-017242-30

• ISRCTN Number

  N/a

• Research summary

  Brief 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. This study is being carried out to see if a new drug called ticagrelor on a background of aspirin therapy decreases the frequency of cardiovascular events (e.g., death from heart or vascular disease, heart attack, or stroke). The study will examine the long-term efficacy and safety of ticagrelor in patients who have sustained a heart attack from one to three years prior to enrolment. Such individuals are at substantially increased risk for another cardiovascular event. This is a randomised, double-blind, three-arm, parallel-group, international, multi-centre study of approximately 21 000 patients in over thirty countries. The study will be event driven and minimum treatment period for a patient is twelve months. Patients will be randomised to either ticagrelor 60 or 90 mg twice daily, or placebo. In addition to ticagrelor or placebo, patients will take once-daily, concomitant aspirin therapy (75 to 150 mg). The primary efficacy endpoint for the study will be time to first occurrence of any cardiovascular event (e.g., death from heart or vascular disease, heart attack, or stroke).

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/63

• Date of REC Opinion

  3 Dec 2010

• REC opinion

  Further Information Favourable Opinion