The PEGASUS-TIMI 54 clinical trial will assess the safety and long-term efficacy of ticagrelor (Brilinta, AstraZeneca) to reduce cardiovascular (CV) events compared to aspirin treatment in acute coronary syndrome (ACS) patients.
The trial, initiated by AstraZeneca and the Brigham and Women’s Hospital-based TIMI (Thrombolysis in MI) study group will enroll 21,000 patients in more than 30 countries and randomize them to receive either 60 mg or 90 mg twice daily of ticagrelor or placebo for a minimum period of 12 months.
In addition, the patients will take a once-daily 75 mg to 150 mg dose of aspirin during the trial.
The researchers will use the time-to-first-occurrence of any CV event including CV death, non-fatal MI or non-fatal stroke as the trial’s primary endpoint.
According to AstraZeneca, current treatment guidelines for ACS patients recommend dual-antiplatelet therapy for up to 12 months post-CV event. The PEGASUS-TIMI trial will aim to evaluate whether a regimen of ticagrelor or aspirin can reduce CV events.
"After a heart attack, patients remain at significant risk of another heart attack or major adverse cardiovascular event,” said Marc S. Sabatine, MD, the study’s principal investigator. “PEGASUS-TIMI 54 will study treatment beyond twelve months after a heart attack, with dual-antiplatelet therapy of ticagrelor and aspirin.”
According to AstraZeneca, the trial will begin patient enrollment during the fourth quarter.