Coronary Stenoses
Conditions
Keywords
antithrombotic strategy, dual antiplatelet therapy
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).
Interventions
DRUGTailored antithrombotic strategy
Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months
DRUGConventional antithrombotic strategy
Clopidogrel + aspirin for 12months
Sponsors
CardioVascular Research Foundation, Korea
Duk-Woo Park, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| The rate of unplanned urgent repeat revascularization | 1 year | Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation |
| Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization) | 1 year | Efficacy outcomes |
| Death | 1 year | Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death |
| BARC major bleeding (type 3 or 5 bleeding) | 1 year | Safety outcomes: Bleeding Academic Research Consortium |
| TIMI major or minor bleeding | 1 year | Safety outcomes: Thrombolysis In Myocardial Infarction |
| GUSTO moderate or severe bleeding | 1 year | Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries |
| ISTH major bleeding | 1 year | Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention |
| Any major or minor bleeding | 1 year | Safety outcomes |
| Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke) | 1 year | Efficacy outcomes |
Countries
South Korea
Outcome results
None listed