CompletedPhase 4

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

Pakistan1,727 participantsStarted 2023-08-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: consecutive patients presenting with ST-elevation myocardial infarction (STEMI) and undergoing primary PCI with drug-eluting stents (DES). \- Exclusion Criteria: * Patients who underwent plain old balloon angioplasty (POBA) or left heart catheterization (LHC) only. * Patients who declined to provide consent. * Patient with high bleeding risk * Prior history of IC hemorrhage * Prior CVA within past one year * On oral anticoagulant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stent Thrombosis

Timeframe: Stent thrombosis occurring 24 hours to 30 DAYS

Trial details

NCT IDNCT06667349

SponsorNational Institute of Cardiovascular Diseases, Pakistan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-03

View on ClinicalTrials.gov More STEMI - ST Elevation Myocardial Infarction trials