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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,727
- 试验地点
- 1
- 主要终点
- Stent Thrombosis
研究概览
简要总结
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.
详细描述
The TISSARA Trial aims to compare the incidence rates of stent thrombosis (ST) and major adverse cardiovascular events (MACE) among patients receiving ticagrelor therapy versus those treated with conventional clopidogrel therapy following primary percutaneous coronary intervention (PPCI) f or ST elevation myocardial infarction at NICVD, Karachi, Pakistan.
Study Cohorts:
- Ticagrelor Cohort: Comprises consecutive patients receiving ticagrelor as part of the dual antiplatelet therapy (DAPT) regimen mandated for a minimum of two weeks post PPCI.
- Clopidogrel Cohort: Included patients who received clopidogrel as part of the conventional DAPT protocol.
Selection Criteria:
• All consecutive patients presenting with ST-elevation myocardial infarction (STEMI) and undergoing primary PCI with drug-eluting stents (DES).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consecutive patients presenting with ST-elevation myocardial infarction (STEMI) and undergoing primary PCI with drug-eluting stents (DES).
排除标准
- •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
研究组 & 干预措施
Tiacgrelor (Tissara) 90 mg pod BID
Ticagrelor 90 mg bid give for atleast two weeks and ideally upto a month
干预措施: Ticagrelor (Drug)
standard arm clopidogrel 75 mg qday
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Stent Thrombosis
时间窗: Stent thrombosis occurring 24 hours to 30 DAYS
A. Definite Stent Thrombosis: Angiographic or pathological confirmation of partial or total thrombotic occlusion within the peri-stent region and at least one of the following additional criteria: Acute ischemic symptoms Ischemic electrocardiogram changes Elevated cardiac biomarkers B. Probable Stent Thrombosis: Any unexplained death \<30 days of stent implantation Any myocardial infarction related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause C. Possible Stent Thrombosis: Any unexplained death beyond 30 days D. Early Stent Thrombosis: Stent thrombosis occurring within 24 hours E. Subacute Stent Thrombosis: Stent thrombosis occurring 24 hours to 30 days
次要结局
未报告次要终点
研究者
Professor Abdul Hakeem
Professor Abdul Hakeem MD FACC FSCAI FASE
National Institute of Cardiovascular Diseases, Pakistan