Clinical trial NCT03465644: TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Stenoses
Keywords: antithrombotic strategy
dual antiplatelet therapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-03-14
Enrollment: 2018
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Age 19 and more
2. Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
3. 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
4. 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 Criteria:

1. Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
2. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
3. Use of Gp IIb/IIIa inhibitors at randomization
4. Cardiogenic shock
5. Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
6. Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
7. 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)
8. History of intracranial hemorrhage or intracranial aneurysm
9. Planned surgery within 180 days
10. Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
11. Platelet count \<80,000 cells/mm3 or hemoglobin level \<10 g/dL
12. At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
13. 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
14. Pregnant and/or lactating women.
15. Concurrent medical condition with a life expectancy of less than 1 years
16. Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
17. Inability to provide written informed consent or participate in long-term follow-up

Primary outcomes:
measure: Net clinical outcome
timeFrame: 1 year
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: Stent thrombosis
timeFrame: 1 year
measure: The rate of unplanned urgent repeat revascularization
timeFrame: 1 year
measure: Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)
timeFrame: 1 year
measure: Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)
timeFrame: 1 year
measure: BARC major bleeding (type 3 or 5 bleeding)
timeFrame: 1 year
measure: TIMI major or minor bleeding
timeFrame: 1 year
measure: GUSTO moderate or severe bleeding
timeFrame: 1 year
measure: ISTH major bleeding
timeFrame: 1 year
measure: Any major or minor bleeding
timeFrame: 1 year
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Cheonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul university Bundang hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St.Carollo Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References: