Xience Registry In Complex Lesion of Acute Coronary Syndrome Patients witH Ticagrelor (RICH)

Study Overview
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Brief Summary
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The goal of this multicenter prospective clinical cohort study is to investigate the impact of early use of low-dose Ticagrelor-based dual antiplatelet agent therapy (TDAPT) (ticagrelor 120mg daily; l-TDAPT) as compared to standard-dose TDAPT (ticagrelor 180mg daily; s-TDAPT) in outcomes of percutaneous coronary intervention (PCI). The main question it aims to answer are: Given the low ischemic risk and high bleeding tendency in Asians, the low dose TDAPT may provide better net clinical benefits of ischemic and bleeding events than the standard dose TDAPT.

Detailed Description
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Participants were administrated with 300mg of Aspirin and 180mg of ticagrelor orally before they underwent index PCI, and were prescribed with s-TDAPT from the next day after index PCI at least for 1 week. The start of l-TDAPT was decided by each attending physician's preference. Successful PCI was defined as a residual stenosis <30% with Thrombolysis in Myocardial Infarction grade 3 flow after PCI and the absence of death by MI and reintervention for the index coronary lesions during the admission period. Standard definitions of cardiovascular events were used for all clinical events. Myocardial infarction (MI) was defined using the 4th universal definition of MI as previously described. Repeat revascularization (RR) was defined as a new PCI for the target vessels or de-novo coronary lesions. All-cause death was defined as a death from any cause. Cardiovascular death was defined as death from MI, stent thrombosis and ischemic stroke. A major adverse cardiac and cerebrovascular event (MACE) was defined as a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke. A bleeding event was defined as the bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher. A net clinical event (NCE) was defined as a composite of MACEs and bleeding events. Patients were scheduled to follow up to 2 years after index PCI. Clinical follow-up started when a patient discharged from the hospitalization for the index PCI and ended when the patient experienced the any clinical event or reached the end of follow-up. The follow-up visits were scheduled at 1, 3 and 6 months, 1 year and 2 years after discharge.

Official Title
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Xience Registry Study for the Impact of Early Use of Low-Dose Ticagrelor-Based Dual Antiplatelet Therapy to Clinical Outcomes in Patient Undergoing Percutaneous Coronary Interventions for Complex Lesions

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years of age or older acute coronary syndrome (ACS) undergoing PCI PCI for complex coronary lesions using everolimus-eluting stents (Xience®, Abbot corp, Chicago, Illinois, US) prescribed with s-TDAPT for more than 3 months Exclusion Criteria: cardiogenic shock PCI using drug-eluting stents (DES) other than the everolimus-eluting stents those who had conditions requiring a long-term oral anticoagulant therapy those with life expectancy <1 year

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| s-TDAPT group<br>Ticagrelor 180mg + Aspirin 100mg within 6 months after index PCI | |
| l-TDAPT group<br>Ticagrelor 120mg + Aspirin 100mg within 6 months after index PCI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A major adverse cardiac and cerebrovascular event (MACE) | a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke. | at 1 years after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | a death from any cause | at 1 years after discharge | 
| cardiovascular death | death from MI, stent thrombosis and ischemic stroke | at 1 years after discharge | 
| Myocardial infarction | the 4th universal definition of MI | at 1 years after discharge | 
| Repeat revascularization | a new PCI for the target vessels or de-novo coronary lesions | at 1 years after discharge | 
| bleeding event | the bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher | at 1 years after discharge | 
| A net clinical event (NCE) | a composite of MACEs and bleeding events | at 1 years after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-dose ticagrelor-based dual antiplatelet agent therapy, Percutaneous coronary intervention, Acute coronary syndrome, Complex coronary lesion, Net clinical outcome, Everolimus-eluting stent