Status:
COMPLETED
TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
Lead Sponsor:
Duk-Woo Park, MD
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Stenoses
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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 aspi...
Eligibility Criteria
Inclusion
- Age 19 and more
- Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
- Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related 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
- The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
Exclusion
- Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
- Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
- Use of Gp IIb/IIIa inhibitors at randomization
- Cardiogenic shock
- Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
- Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (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 intracranial aneurysm
- Planned surgery within 180 days
- Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
- Platelet count \<80,000 cells/mm3 or hemoglobin level \<10 g/dL
- At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
- Use of 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
- Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
- Inability to provide written informed consent or participate in long-term follow-up
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2025
Estimated Enrollment :
2018 Patients enrolled
Trial Details
Trial ID
NCT03465644
Start Date
February 12 2019
End Date
February 13 2025
Last Update
June 6 2025
Active Locations (22)
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1
Hallym University Sacred Heart Hospital
Anyang, South Korea
2
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
3
Gyeongsang National University Changwon Hospital
Changwon, South Korea
4
Chungbuk National University Hospital
Cheonju, South Korea