TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).

Official Title
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Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late De-Escalation Strategy Versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention

Conditions
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Coronary Stenoses

Intervention / Treatment
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* Drug: Tailored antithrombotic strategy
* Drug: Conventional antithrombotic strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 and more Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent At least one of the following high-risk clinical, lesion or procedure-related risk factors; Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or low left ventricular ejection fraction (<40%) or Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length ≥ at least 30 mm), multi-vessel PCI (≥ 2 vessels requiring stent implantation), ≥3 requiring stent implantation, ≥ 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm Exclusion Criteria: Enzyme-positive Acute myocardial infarction(NSTEMI or STEMI) Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel) Subject using Gp IIb/IIIa inhibitors at randomization Cardiogenic shock or Severe LV dysfunction(LV ejection fraction <30%) at the index admission Subject treated with only BMS or balloon angioplasty during the index procedure. Need for chronic oral anticoagulation (warfarin or NOACs) Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding) History of intracranial hemorrhage or intra cranial aneurysm Planned surgery within 180 days Subjects with Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening who meet the following criteria 1) Platelet count < 80,000 cells/mm3 2) Hb <10 g/dL Subject at risk of bradycardia (Subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but not inserted permanent pacemaker) Subjects taking strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment : Ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital Pregnant and/or lactating women. Concurrent medical condition with a life expectancy of less than 1 years Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. Subject was unable to provide written informed consent or participate in long-term follow-up.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored arm<br>early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy | Drug: Tailored antithrombotic strategy<br>* Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months<br>|
| Active Comparator: Conventional arm<br>clopidogrel + aspirin for 12months | Drug: Conventional antithrombotic strategy<br>* Clopidogrel + aspirin for 12months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net clinical outcome | a net clinical outcome of all-cause death, MI, stroke, stent thrombosis, urgent revascularization and clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months post-PCI. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 1 year | 
| Myocardial infarction |  | 1 year | 
| Stroke |  | 1 year | 
| Stent thrombosis |  | 1 year | 
| Urgent revascularization |  | 1 year | 
| Clinically relevant bleeding | Bleeding Academic Research Consortium (BARC) 2, 3, or 5 | 1 year | 
| Composite of death (all or cardiovascular), MI, or stroke, stent thrombosis or urgent revascularization |  | 1 year | 
| Composite of death (all or cardiovascular), MI, or stroke |  | 1 year | 
| Composite of death (all or cardiovascular) or MI |  | 1 year | 
| Any revascularization |  | 1 year | 
| BARC type 3 or 5 bleeding |  | 1 year | 
| Major or minor bleeding according to definitions from The Thrombolysis in Myocardial Infarction (TIMI) |  | 1 year | 
| Major or minor bleeding according to definitions from International Society of Thrombosis or Hemostasis (ISTH) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antithrombotic strategy, dual antiplatelet therapy