TISSARA Trial: Ticagrelor Intervention to Reduce Stent Thrombosis and Acute MI Risk

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.

Timeline

Start

2023-08-24

Primary completion

2024-03-03

Completion

2024-06-16

Publications

• Background Kumar R, Ammar A, Saghir T, Sial JA, Shah JA, Kumar A, Shaikh AH, Achakzai AS, Qamar N, Karim M. Incidence, Predictors, and Outcomes of Acute and Sub-acute Stent Thrombosis after Emergency Percutaneous Coronary Revascularization with Drug-Eluting Stents: A Prospective Observational Study. Glob Heart. 2022 Mar 30;17(1):24. doi: 10.5334/gh.1112. eCollection 2022.
• Background Schulz S, Schuster T, Mehilli J, Byrne RA, Ellert J, Massberg S, Goedel J, Bruskina O, Ulm K, Schomig A, Kastrati A. Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period. Eur Heart J. 2009 Nov;30(22):2714-21. doi: 10.1093/eurheartj/ehp275. Epub 2009 Jul 11.
• Background Dubey G, Verma SK, Bahl VK. Primary percutaneous coronary intervention for acute ST elevation myocardial infarction: Outcomes and determinants of outcomes: A tertiary care center study from North India. Indian Heart J. 2017 May-Jun;69(3):294-298. doi: 10.1016/j.ihj.2016.11.322. Epub 2016 Nov 30.

Drugs

Indications