TISSARA Trial: Ticagrelor Intervention to Reduce Stent Thrombosis and Acute MI Risk
Status:
COMPLETED
Trial end date:
2024-06-16
Target enrollment:
Participant gender:
Summary
Stent thrombosis (ST) remains a critical complication following primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI). At the National Institute of Cardiovascular Diseases in Karachi-recognized as the world's busiest PPCI center-reported rates of ST range from 4% to 6%. In response to this pressing issue, the health system has implemented a new two-week post-PCI regimen featuring ticagrelor, aimed at enhancing patient outcomes and reducing the risk of stent-related complications.
The TISSARA Trial is designed to rigorously assess the effectiveness of this intervention on cardiovascular outcomes in STEMI patients.
Between August, 2023 and March 2024, a total of 1,773 patients were enrolled in the trial, with 970 patients discharged on Tissara (Ticagrelor) (Ferozsons laboratories Ltd, Lahore, Pakistan) (TG) and 803 patients receiving clopidogrel (CG) following their primary PCI procedures. Each group was carefully monitored for a duration of three months to evaluate the incidence of stent thrombosis and other relevant cardiovascular events. The primary endpoint of this trial is the occurrence of stent thrombosis within the follow-up period, providing critical insights into the safety and efficacy of the ticagrelor regimen in this high-risk population.
This comprehensive approach aims to contribute valuable data that may influence future treatment protocols and improve the standard of care for patients undergoing PCI in similar healthcare settings.
Phase:
PHASE4
Details
Lead Sponsor:
National Institute of Cardiovascular Diseases, Pakistan