TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
- Conditions
- Coronary Stenoses
- Interventions
- Drug: Conventional antithrombotic strategyDrug: Tailored antithrombotic strategy
- Registration Number
- NCT03465644
- Lead Sponsor
- Duk-Woo Park, MD
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2018
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Age 19 and more
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Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
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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
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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.
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Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
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Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
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Use of Gp IIb/IIIa inhibitors at randomization
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Cardiogenic shock
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Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
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Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
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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)
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History of intracranial hemorrhage or intracranial aneurysm
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Planned surgery within 180 days
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Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
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Platelet count <80,000 cells/mm3 or hemoglobin level <10 g/dL
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At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
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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
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Pregnant and/or lactating women.
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Concurrent medical condition with a life expectancy of less than 1 years
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Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
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Inability to provide written informed consent or participate in long-term follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional arm Conventional antithrombotic strategy clopidogrel + aspirin for 12months Tailored arm Tailored antithrombotic strategy 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
- Primary Outcome Measures
Name Time Method Net clinical outcome 1 year a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\] at 12 months after randomisation
- Secondary Outcome Measures
Name Time Method Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization) 1 year Efficacy outcomes
BARC major bleeding (type 3 or 5 bleeding) 1 year Safety outcomes: Bleeding Academic Research Consortium
GUSTO moderate or severe bleeding 1 year Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries
TIMI major or minor bleeding 1 year Safety outcomes: Thrombolysis In Myocardial Infarction
Any major or minor bleeding 1 year Safety outcomes
ISTH major bleeding 1 year Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention
Death 1 year Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death
Myocardial infarction 1 year Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction
Stroke 1 year Efficacy outcomes: any, ischemic, or hemorrhagic Stroke
Stent thrombosis 1 year Efficacy outcomes
Repeat revascularisation 1 year Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation
Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke) 1 year Efficacy outcomes
Trial Locations
- Locations (22)
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Gangwon National Univ. Hospital
🇰🇷Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheonju, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Dong-A Medical Center
🇰🇷Pusan, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Bundang CHA Hospital
🇰🇷Seongnam, Korea, Republic of
Seoul university Bundang hospital
🇰🇷Seongnam-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
🇰🇷Seoul, Korea, Republic of
St.Carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, ST. Mary's Hospital
🇰🇷Suwon, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of