Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late DeEscalation Strategy versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Interventio

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002917
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Subject was > 19 years of age
2. Subjects who scheduled for PCI with contemporary DES
3. Patients must have at least one of any features of complex high-risk anatomic, procedural, and clinical-related factors
A.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
B.Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or severe left ventricular dysfunction (LVEF <40%)
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides 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(NSTEMI or STEMI)
2. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
3. Subject using Gp IIb/IIIa inhibitors at randomization
4. Cardiogenic shock or Severe LV dysfunction(LV ejection fraction <30%) at the index admission
5. Subject treated with only BMS or balloon angioplasty during the index procedure.
6. Need for chronic oral anticoagulation (warfarin or 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 intra cranial aneurysm
9. Planned surgery within 180 days
10. 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
11. Subject at risk of bradycardia (Subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but not inserted permanent pacemaker)
12. 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
13. Pregnant and/or lactating women.
14. Concurrent medical condition with a life expectancy of less than 1 years
15. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
16. Subject was unable to provide written informed consent or participate in long-term follow-up.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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]

Secondary Outcome Measures

Name	Time	Method
Stroke;Stent thrombosis;Urgent revascularization;Clinically relevant bleeding_Bleeding Academic Research Consortium (BARC) 2, 3, or 5;All cause death;Composite of death (all or cardiovascular), Myocardial infarction(MI), or stroke, stent thrombosis or urgent revascularization;Composite of death (all or cardiovascular), MI, or stroke;Myocardial infarction;Composite of death (all or cardiovascular) or MI;Any revascularization;BARC type 3 or 5 bleeding;Major or minor bleeding according to definitions from The Thrombolysis in Myocardial Infarction (TIMI);Major or minor bleeding according to definitions from International Society of Thrombosis or Hemostasis (ISTH)