NCT06667349CompletedPhase 4
TISSARA Trial: Ticagrelor Intervention to Reduce Stent Thrombosis and Acute MI Risk
Ticagrelor Intervention to Suppress Stent Thrombosis and Acute MI Risk (TISSARA) Trial: An LMIC Health System Initiative in the World's Busiest Primary PCI Center
Source: ClinicalTrials.gov · Last updated 31 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1727 (actual)
- First submitted
- 28 Sept 2024
- Start date
- 24 Aug 2023
- Primary completion date
- 3 Mar 2024
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Diseases
- Coronary artery disease
- NCT number
- NCT06667349
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1727
- From 24 Aug 2023 to the primary completion date, 3 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- \-
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Cardiovascular Diseases Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.